translational strengths at ohsu translational strengths at ohsu (stint) study was conducted by the...

TR ANSL ATIONAL STRENGTHS AT

OHSU2 0 1 3

Translational Strengths at OHSU (STINT) Conducted & Prepared by: OCTRI Office of Research Impact [email protected] January, 2014

Full Report

Ta b l e o f Co n T e n Ts

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OregOn CliniCal and TranslaTiOnal researCh insTiTuTe

3 Introduction 5 Executive Summary

9 Recommendations Summary

11 Why assess translational strengths?

14 Methodology19 Results 20 Translational Definition

24 Demographic Results

27 Referrals

34 Strengths and Opportunities

41 Barriers

46 $100 Million: Translational Funding Priorities

51 OCTRI 55 Data Stories 59 Discussion and Limitations60 Recommendations Summary Table61 References

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Study Team

The Translational Strengths at OHSU (STINT) study was conducted by the OCTRI Office of Research Impact. The goals of the OCTRI Research Impact team are 1) to ensure that OCTRI is a learning organization by contributing to strategic planning and internal data analysis, 2) to lead and/or participate in OHSU-wide efforts to characterize the translational landscape, and 3) to contribute knowledge to the CTSA consortium and the field of biomedical research impact. The OCTRI Research Impact team consists of Dr. Adrienne Zell, Evaluation Manager, Lindsey Smith, MPP, OCTRI Evaluation Research Assistant, and Dr. David Dilts, Former Evaluation Director.

Credits

The OCTRI Office of Research Impact would primarily like to thank all STINT respondents. Each interviewed researcher gave generously of their time, their opinions, and their enthusiasm for our process. In addition, we would like to thank OCTRI Leadership for their support of this project and Erica Zeigler, OCTRI Communications Specialist, for her contribution to the report template. Ryan Pelkey and Denise Duncan assisted with proofing and formatting. Mai-Lee Yap, OCTRI Regulatory Specialist, assisted with IRB submission.

Internal Review Board & Confidentiality

The STINT study was conducted with the full approval of the OHSU IRB (IRB00009104). Potential subjects were notified of any and all risks relevant to participation. All subjects were informed of the confidentiality of their responses; only the three aforementioned members of the OCTRI Evaluation team had access to non-blinded data. Quotes that have the potential to identify their source were not selected for inclusion in this report.

Report Recommendations

Recommendations listed in this report were derived from STINT study results and independently selected for inclusion by the STINT study team. Included recommendations may or may not reflect the opinions of OCTRI leadership and/or staff. When selecting recommendations, the STINT study team considered the following: probable actionability of each suggested recommendation, degree of overlap with existing improvement efforts, and magnitude of potential impact.

Translational Strengths at OHSU : Introduction2013

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Report Terminology

Translational Axis

The term translational axis is commonly used to classify biomedical research along a spectrum of translation from lab research to policy development. Although consensus remains elusive regarding both the number and definition of “T” axes, the construct remains useful in describing the different types of translational research. This report uses the terms as described by Leshner et al in their recent review of the Clinical and Translational Science Awards (CTSAs), “The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research.” (15) These five stages are defined as follows:• T0 - Basic science research, including pre-clinical and animal studies• T1 - Translation to humans, including proof of concept and phase 1 clinical trials• T2 - Translation to patients, including phase 2 and 3 clinical trials• T3 - Translation to practice, including phase 4 clinical trials and outcomes research• T4 - Translation to community, including population-level outcomes research

Organizations

Throughout this report the term organizations is used broadly to refer to OHSU Departments, Divisions of the Department of Medicine, Centers, Institutes, and Networks. Researchers and research leaders were affiliated with their home organization as it appears in OHSU human resources data. The study team recognizes that investigators can have multiple affiliations.

Investigators

The STINT study sample included four individuals who were identified as research leaders rather than investigators. These individuals may have active research portfolios, yet their primary contribution to translational research is the shaping of institutional policies and priorities. Throughout this report, the entire sample is often referred to as investigators or researchers.

Translational Strengths at OHSU : Introduction2013

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ex e C u T i v esu m m a ry

Strengths in Translation at OHSU (STINT)In Spring of 2013, the OCTRI Office of Research Impact interviewed 51 OHSU translational researchers and research leaders with the purpose of better understanding areas of strengths and barriers in translational research. Ten faculty with strong records of grant funding in translational research were selected as initial participants, and 41 additional participants were identified by earlier interviewees as being active in translation. Common in qualitative studies, this snowball sampling process allows for mapping and analysis of referral networks. A mixed-methods approach was used for the analysis, combining respondent demographic data, referral network maps, and coded qualitative narratives. Illustrative quotes and recommendations are included in each major report section.

Defining TranslationThis component is largely geared towards assisting OCTRI and OHSU to understand the perceptions of translational research. To frame this section of the interviews, each respondent was asked to define translational research. The classic definition, “bench to bedside” received the most responses, yet other definitions were also mentioned frequently including “product to market” and “clinical trials.” Although basic science was not excluded from proposed definitions, the majority of respondents believe that translational research should have a tangible human impact. At the other end of the translational spectrum, community and policy research was infrequently called out. A few researchers spoke of translational research as the “intent to translate”, a definition which could theoretically encompass all of biomedical research.Results from this component suggest that OCTRI clarify its role and activity on the far ends (basic, community) of the translational continuum. Both OCTRI and OHSU should consider selecting a definition of translation that can be used consistently and that clearly conveys the overall mission of translational research.

Strengths in Translational ResearchSTINT results identify more than eleven established scientific strengths at OHSU, with cancer and neurology receiving the most mentions. Attempts to uncover emerging strengths were less successful. Cardiology received the most references as an emerging strength, with several other disciplines mentioned by only a couple of researchers each. A key result, however, is that respondents’ reasoning tended to stratify into five distinct dimensions. Areas of scientific translational strength were identified for their leadership, human capital, funding, culture, and/or impact. Analysis of narrative data exposed recurring areas within each dimension which inspired a proposed framework (below) for evaluating and classifying potential strengths. Although thresholds for confirming an area as currently strong will differ across oranizations, disciplines that contain elements of all five dimensions may be considered translational research strengths, while those that contain fewer dimensions and/or elements may be considered emerging strengths. This framework can be used informally or aligned with a more rigorous data gathering and evaluation process. It is recommended that OHSU leadership use this or a similar framework when identifying strengths to avoid investing in areas that are strong in only one or two dimensions.

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BarriersBarriers were classified into five themes: financial resources and time available, infrastructure and cores, leadership, communication, and demographics. Declining national funding for translational research was viewed as a barrier, as was the low number of viable internal funding options. Local funding options referenced include institutional bridge funding, departmental support for physician-scientists, and OCTRI pilot grants. The STINT study team recommends, where possible, increasing the availability and diversity of internal funding options for translational research. Under infrastructure, eleven categories of barriers and their corresponding examples were included in the results. Researchers provided examples of research support services that are perceived to be overly risk-averse and/or too slow, processes that make it difficult to participate in multi-institutional projects, and cores that are too expensive and/or underfunded. Although process improvement efforts are currently underway in many of these areas (IRB, for example), it is recommended that specific barriers to cross-institutional research be identified and addressed. Respondents also attributed certain barriers to OHSU leadership. A common perception is that clinical work is prioritized at the expense of research and that the relationship between the hospital and the research components of OHSU is strained. Many interviewees believe that institutional goals are too broad and are poorly communicated to the research community. Additional communication barriers were highlighted, particularly those that exist among basic and clinical departments and their corresponding researchers. Recommendations derived from discussion of non-infrastructure barriers emphasize the need for improvements in communication across the University.

Leadership People Funding Culture Outcomes & Impact

Scientific leadership

Research stars High external funding $$

Multidisciplinary Traditional: publications, new funding

Organizational leadership

Critical mass of researchers

High level of institutional support

Translational External recognition

Leadership support from institution

Diversity in career stages of researchers

Diversified funding stream

Collaborative Impact, reproducibility

Community, network, extra-mural support

Large #s of patients

Generally high likelihood of sustainability

Unique/highly focused

Non-traditional, alt-metrics

Strengths Identification Framework

In addition to scientific strengths, internal organizations that were perceived as strengths include the Oregon National Primate Research Center (ONPRC), Biomedical Engineering, and the OCTRI Education program. Cultural strengths were also discussed. Researchers praised OHSU’s collegial atmosphere and small size as supportive of collaboration. Respondents also highlighted the existence of physician-scientists and their role as translational bridges, or boundary-spanners. The STINT study team recommends that OHSU capitalize on the small size of OHSU to maximize meaningful collaborations that may be more difficult to achieve at other institutions.

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Research PrioritiesIn addition to inquiring about strengths and barriers, the study team asked participants how they would prioritize spending of a fictional $100 million grant for translational research. Results overlapped with themes from strengths and barriers, with internal funding, infrastructure, and time for research receiving the greatest number of suggestions. Participants had suggestions for OHSU: augment clinical research infrastructure, recruit faculty that span basic-clinical and departmental boundaries, learn about best practices before investing in change, and “be unique” to stand out among other universities.

OCTRIRespondents were asked about their experiences with and perceptions of OCTRI. Most researchers had strong praise for OCTRI, highlighting OCTRI leadership, the emerging Biomedical Innovation Program (a pilot award), and the OCTRI Education program. Interviewed researchers were, however, generally uninformed about OCTRI’s overall goals, translational territory, and range of offerings. This is a key communication gap, given that the majority of STINT respondents have been a principal or co-investigator on an OCTRI project. Recommendations for OCTRI from interviewed researchers and from the study team focus primarily on communication, but also include: improving identification of OCTRI’s customer and non-customer base, disseminating OCTRI participation data and making personal connections, and considering additional services such as a “research concierge”.

Research Leaders

Preclinical

Clinical Community

Policy

Research Leaders

Preclinical

Clinical Community

Policy

Combining DataA key STINT result highlights the ambiguous role of community and policy research in the translational research community. Triangulation of institutional, referral, and interview data show that although there are well-funded, established, community and policy researchers at OHSU their role in the translational landscape is not always clear. Figure a (right) shows the multitude of connections between OHSU translational researchers (identified by interviewed investigators as part of the study methodology), while Figure b shows connections to community and policy researchers.Although community and policy research is considered a translational strength by a few researchers, community and policy researchers themselves appear less connected to their translational colleagues.

a) All Connections by Research Typeb) Connections to Community and Policy Researchers

a)

b)

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Limitations There are two key limitations to the methodology and results of the STINT study. The first concerns the study sample, which consists primarily of well-funded, established researchers. The initial sample was drawn from a ranked dataset of institutional grants data, with the most highly funded researchers selected for inclusion. Although the subsequent sample referral process allowed researchers to refer to any researcher on campus, referrals were mainly to other well-funded, established researchers. Young, early-career researchers were not well represented in the STINT sample and may have different opinions as to strengths and barriers. In addition, well-resourced researchers may be less likely to utilize OCTRI services. The second limitation concerns the tendency of interviewed researchers to self-identify as siloed. More than half the interviewed researchers made at least one comment referencing their relative isolation. This result seemed particularly prevalent for cancer researchers, and may have resulted in additional participants in STINT based primarily on reputation rather than direct knowledge of their science.

Next Steps & Future Directions• As noted above, the STINT sample contains mainly senior, well funded investigators. Future investigations should focus on identifying translational strengths and barriers faced by others, including younger and less established researchers, as their needs are often different. • Due to the relatively small number of researchers interviewed, particularly within some departments, attempts to identify areas of strong translational culture, or translational silos, were intriguing but limited. • Additional data should be collected on the strengths mentioned in this report. Data should be collected across all dimensions presented in the proposed framework.

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re Co m m e n daT i o n ssu m m a ry

Throughout this report, the STINT study team has included recommendations. Below is a summarized list of these recommendations, along with a brief rationale for each. As mentioned in the report notes, the STINT study team considered the following factors: potential actionability of each suggested recommendation, degree of overlap with existing improvement efforts, and magnitude of potential impact.

Recommendations for OHSU

StrengthsConsistent strengths identification: Interviewees identified strengths across several dimensions; most disciplines were not strong in all dimensions. The STINT study team developed a framework (Table 4) for identifying strengths that increases the likelihood of a strength meeting the criteria across leadership, human capital, funding, culture, and impact.Collaboration: Respondents believe that the small size of OHSU allows for collaboration and collegiality. However, barriers remain. The STINT study team recommends that leadership capitalize on the small size of OHSU to encourage collaborative efforts that may not be possible at other AMCs. Because cancer researchers have translational strengths, but seem somewhat siloed, it is recommended that additional cancer + non-cancer collaborations be considered.

BarriersInternal funding: Not surprisingly, the decline of external research funding is a barrier to translational research. In response, OHSU researchers would like to see greater availability and communication of internal funding options such as bridge funding, departmental resources, and pilot awards.Multi-institutional projects: Identified barriers included infrastructure and cores that make it difficult for OHSU researchers to engage in multi-institutional research protocols. The STINT study team recommends that core process improvement efforts specifically identify policies and procedures that impede cross-institutional work and prioritize amelioration. Communication: Two communication barriers particularly resonated with STINT respondents; communication between the research and hospital missions (including communication of institutional goals) and communication between basic and clinical entities. It is recommended that OHSU leadership implement strategies to increase transparency of communication between the research and clinical care components of the institution and identify possibilities for increased communication across the translational spectrum.

Translational Research PrioritiesRespondents had several suggestions for prioritizing translational research: identify needs and make improvements to all phases of clinical research infrastructure, recruit translational faculty that traverse basic and clinical departments, gather data on best practices from other institutions when considering changes, and focus on what makes OHSU unique.

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re Co m m e n daT i o n ssu m m a ry

Recommendations for OCTRI

Translational DefinitionBasic science: Many researchers believe that basic science is a component of translational research, referring to the researcher’s intent to translate the findings. OCTRI should identify the prevalence of basic scientists in its investigator roster and consider how support of basic science aligns with OCTRI goals.Community: Although OHSU community and policy researchers are considered a strength, they received few referrals from their university colleagues and their role in the translational landscape remains ambiguous. It is recommended that OCTRI clearly define and communicate its role in supporting community and policy research at OHSU.Mission: Researchers proposed varying definitions of translational research. As part of it’s mission, OCTRI should select a definition of translation and communicate it consistently to OCTRI staff and the wider OHSU community.

Suggestions for OCTRIStrategy: OCTRI should take a lead role in OHSU discussions and policy regarding translational research, communicating coordinated translational strategy to all researchers.Marketing: Respondents suggested that OCTRI make personal connections with departments at OHSU, disseminating OCTRI participation data to engage researchers. Customers: Many interviewed investigators believe that OCTRI should focus on helping young and/or early career researchers. OCTRI should analyze the demographics of its customer base, identifying proportions of early career investigators and comparing OCTRI users to OHSU overall. Services: OCTRI is in a position to be able to assist with improvements in communication, connectivity, and collaboration among OHSU researchers. One suggestion is the implementation of a “research concierge” service that would facilitate collaboration and access to translational resources.

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TRANSLATIONAL STRENGTHS AT OHSU

in T r o d u C T i o nWhy assess translational strengths?

Why Assess Translational Strengths?

NCATS RFA » CTSAS are instructed

to “develop and build upon unique

institutional and community strengths”

OCTRI Strategy » Cyclical strategic

planning efforts underway at OCTRI » Alignment of OCTRI

goals, activities, and budgets

Research Roadmap » Key role of OCTRI

leadership in OHSU Research Roadmap investments » Parallel OCTRI/

Roadmap goals

In 2006, the National Institutes of Health (NIH) established the Clinical and Translational Science Awards (CTSA) with a mission to increase the quality, safety, efficiency, and speed of clinical and translational research (2). As a CTSA awardee, The Oregon Clinical and Translational Research Institute (OCTRI) is a member of a Consortium of 61 CTSAs housed at academic medical centers throughout the United States. At its home institution, Oregon Health and Science University (OHSU), OCTRI serves as the integrated home for clinical and translational research and provides a coordinated infrastructure of core services to biomedical researchers (3). OCTRI is funded primarily through the CTSA program. Additional funding sources include institutional commitment from OHSU and cost recovery from services provided to researchers.

From 2006 to 2011, the CTSA program was administered by the National Center for Research Resources (NCRR). In 2011, responsibility for CTSAs was transferred to the National Center for Advancing Translational Sciences (NCATS), and a new RFA for CTSA funding was released. Existing CTSAs will be applying for new funding on a cohort cycle, with OCTRI responding in FY 2016. Figure 1 illustrates the relationship of OCTRI to NIH, NCATS, the CTSA Consortium, and OHSU.

NCATS

OCTRI CTSA Consortium

NIH

OHSU

FIGURE 1: NIH TO OCTRI

2013

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A key statement contained within the new NCATS RFA requests that proposed CTSAs leverage their strengths when designing services for biomedical investigators, “Institutional CTSAs are encouraged to develop programs tailored to meet the needs of their own investigative and public communities and to develop and build upon unique institutional and community strengths.” (2) Partially as a result of this language, OCTRI leadership and the OCTRI Office of Research Impact decided to launch a qualitative study with the goal of identifying strengths, weaknesses, and barriers in translational research at OHSU. The selected approach, entitled Strengths in Translation, or STINT, was designed to maximize actionability of the results by using internal evaluators, focusing specifically on translational research, and soliciting feedback specific to OHSU and applicable to OCTRI.

In addition to the CTSA RFA, two ongoing local initiatives provided additional motivation for STINT — OCTRI strategic planning and the OHSU Research Roadmap. OCTRI strategic planning efforts occur cyclically, with current activity focused on refining and operationalizing OCTRI goals in the current budget context. The Research Roadmap is a multi-year OHSU School of Medicine planning effort intended to guide the scientific focus and strategic direction of the School of Medicine research mission (4), and involves OCTRI faculty and staff. Identification of research strengths is a goal common to both OCTRI and the OHSU Research Roadmap. Other common goals include improvement in efficiency and effectiveness of the research process and measurement of research productivity.

In general, as federal resources for biomedical research continue to contract, awareness of local strengths and weaknesses is critically important to targeting goals and allocating financial investments. Stakeholders of STINT results include OCTRI leadership and staff, OHSU leadership, OHSU Research Roadmap leadership and committee members, members of the CTSA consortium, and other analysts and strategic planners who may be interested in the methodology used for this strengths assessment.

For the STINT project, a mixed-method evaluation design was proposed, integrating qualitative interviews of OHSU translational researchers as a primary data source with existing institutional grants data as a secondary data source. This design had several advantages. First, conducting in-person interviews of OHSU researchers allowed OCTRI evaluation staff to personally connect with OHSU researchers. Second, it allowed OCTRI to use existing resources and staff to complete the study and was therefore inexpensive. Third, the use of a primarily qualitative approach provided the opportunity to probe for emerging and less widely held beliefs about strengths, barriers, and weaknesses. Finally, the increased knowledge of the research landscape gained by interviewing a demographically diverse sample of investigators has long-term knowledge acquisition advantages that go beyond this particular study.

Translational Strengths at OHSU : Introduction

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A unique feature of the STINT design was the use of snowball sampling. Snowball sampling, also known as chain-referral sampling, is a process in which an initial core sample is identified through traditional methods with future respondents identified and referred by their peers. Snowball sampling provides an additional methodological advantage which is the development, description, and illustration of a professional awareness network. Although referral networks are based on awareness of colleagues and their work, not direct academic collaborations, they are useful in identifying groups that may be either particularly prominent or particularly isolated.

Qualitative research is designed to identify, present, and illustrate themes. For the STINT study, the addition of quantitative data from existing data sources is intended to add depth to those themes. The combined approach aims to reduce reliance on anecdotalism in decision-making, but falls short of the statistical precision required to state with certainty the exact prevalence of each theme across the entire population of OHSU translational researchers. The results and recommendations of the STINT study should be considered within the context of both the advantages and the limitations of qualitative evaluation research.

Translational Strengths at OHSU : Introduction

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STINT me T h o d o lo g y

The STINT study team interviewed translational researchers across OHSU departments and institutions.

For the STINT project, a mixed-method evaluation design was proposed, integrating qualitative interviews of OHSU translational researchers as a primary data source with existing institutional data as a secondary data source. Snowball sampling was used to select interviewees beyond the initial sample and to create a referral network.

The primary methodology for STINT was a set of qualitative interviews. A semi-structured, IRB-approved, interview guide was created with eight questions covering the general constructs of strengths, barriers, and weaknesses of translational research at OHSU. Subject consent was obtained through acceptance of the interview invitation. Interviews were conducted by members of the OCTRI Evaluation team. Interviewers probed for specific responses addressing current versus emerging strengths, scientific disciplines, research processes, resources, organizational culture, and the perceived role of OCTRI. In addition, to further solicit opinions on preferences and priorities, participants were offered a fictional $100 million dollar grant for translational research and were asked how they would spend the money. At the close of each interview, subjects were asked to participate in the snowball sampling process by referring the study team to additional translational researchers at OHSU. All participants were interviewed in person at the location of their choosing, typically in their office or in a conference room.

Interviews

Sample of Translational ResearchersBefore snowball sampling can be implemented, an initial sample must be identified. For STINT, the initial sample of 10 potential respondents was selected from institutional data on grant dollars awarded to OHSU researchers. Because there are over 1,400 investigators conducting research at OHSU, this was primarily a process of elimination rather than identification.

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Interviews » In-person interviews

of OHSU translational researchers

» Interviews conducted by OCTRI Evaluation staff

» IRB-approved interview guide

Snowball Sampling » Each researcher

was asked to refer the study team to additional translational researchers at OHSU

» Allows for the development of a referral network map

Institutional Data » Grants data & IRB flag » OCTRI services data » Human resources data

Key Methodology Components

Translational Strengths at OHSU: Methodology 2013

Two goals drove the process of selecting the initial sample, 1) select researchers with a wide range of knowledge of the OHSU translational landscape, and 2) select researchers who do translational research. To address goal #1, it was theorized that highly funded researchers who have conducted research at OHSU for at least five years would have an in-depth view of strengths and barriers. Five-year cumulative grant dollars were totaled for each principal investigator and rankings were assigned. Researchers not ranked in the top 100 of the most highly funded investigators were eliminated from consideration for the initial sample (but could still become participants through the snowball sampling process).

To address goal #2, each investigator was assigned a clinical research prevalence score derived from the percentage of their PI grants flagged with an IRB tag, the percentage of their projects with a clinical department as the award-owning organization, and the clinical/basic designation of their home department. Although this is a rough measure, the purpose was to eliminate researchers who only do basic research and therefore might not be able to confidently address translational strengths and barriers. Researchers with a derived clinical research prevalence score of zero, indicating basic researchers, were eliminated from consideration for the initial sample (but could still become participants through the snowball sampling process). Other considerations in selecting the initial sample included cross-checking for representation from highly funded departments.

The final sample for initial contact consisted of 10 highly funded translational researchers. When determining a projected sample size for the initial protocol, the STINT team proposed an a-priori cap of 40 researchers, which included the 10 initial contacts plus additional investigators referred by their peers. In qualitative research, sample size considerations include a) the capacity and resources of the study sponsor, and b) the possibility of discovery failure. Discovery failure references the possibility that a qualitative sample that is too small will fail to capture all perceptions that might be important to the constructs being investigated. (5) When sampling for one group or subgroup, a recommended sample size for in-depth qualitative interviews (IDIs) is n=30, a sample size that reduces the risk of missing a non-majority perception to between two and five percent. (5)

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Translational Strengths at OHSU: Methodology2013

The OHSU researcher pool, however, consists of multiple subgroups such as departments and institutes, research interests, gender groups, and many others. Increasing the sample size to meet the maximum capacity of the study team reduced the possibility of discovery failure, yet the possibility remains that minority perceptions of translational strengths and barriers remain uncovered.

Snowball SamplingSnowball sampling, also known as chain referral or respondent-driven sampling, is a process in which each respondent is asked to identify additional respondents. (6) For STINT, each respondent was asked for referrals to additional translational researchers. There are two primary advantages to snowball sampling. First, snowball sampling allows evaluators to identify “hidden populations,” or potential participants not easily detected from quantitative data sources. For the STINT project, it was anticipated that these hidden populations would consist of emerging translational researchers not readily identifiable from institutional data. Second, snowball sampling allows for mapping and analysis of the professional awareness network that exists among respondents. For example, during the analysis phase, questions can be asked about the number and origin of referrals received by each researcher. This network data becomes even richer when supplemented with existing demographic data. For STINT, institutional data on departments, translational axis designation, and total allocated grant dollars were added to the network analysis. Disadvantages of snowball sampling include selection bias and concerns about representativeness of the final sample. For the strengths study, the concern was that respondents with limited networks would refer researchers by reputation rather than from direct knowledge of their translational work.

Interview QuestionsInterview questions were designed to closely follow the study constructs and themes, also allowing for appropriate prompts and expansion of the concepts. Prompts were planned for in the interview design, but not scripted. Prompts for strengths and barriers included scientific disciplines, research processes, resources, and organizational culture. Following the approved STINT IRB protocol, participants who requested the study questions received them via email prior to the interview.• What is your role in translation?• Define Translational Research• What are OHSU’s strengths in translational

research?• What are some emerging strengths?• What are some barriers? What makes it hard

to do translational research well here?

• What do you think of OCTRI?• If you had $100 million for translational

research at OHSU, how would you spend it?• Who else does translational research well

here?

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Qualitative Data » Coded using qualitative

analysis software » Data reduction using

prevalence score matrices

Referral Network » Referral network

maps programmed in javascript

» Counts of to/from referrals

Institutional Data » Grants data & IRB flag » OCTRI services data » Human resources data

Combined Analyses » Combine analyses to

tell stories & make recommendations

Key Analysis Components

Prior to analysis of respondent demographics, each investigator was assigned an organization, a five-year funding total, and a translational axis designation. Organizational and funding data came from OHSU human resources and grants data, respectively. The study team applied translational axis labels, with the understanding that a researcher’s overall portfolio may contain protocols at different points along the translational spectrum. The first tier of the analysis, ranking and categorization of researchers and their associated departments by funding and translational axis, provided a framework for the next three stages of analysis.

The second tier of the analysis was the mapping and charting of referral data. Each investigator, or node, has one or more ties to other individuals with each tie representing a referral either to or from another translational researcher. Nodes and ties were illustrated on a series of circular network maps, programmed in javascript for both static (reporting) and dynamic use. Labels indicating organizations, funding levels, and translational axes were applied to the maps. In addition, tables were produced listing actual values from the referral data. Examples include the number of overall referrals to each department and the number of internal and external referrals.

The third and fourth tiers of the analysis, coding and data reduction, were applied to the qualitative interview data. A coding scheme was developed iteratively as the interviews progressed, and each completed interview was coded by two separate members of the STINT study team. An inter-rater reliability score of .83 was calculated for the two coders, indicating a high level of agreement. (7,8) All coding and report generation was done using Dedoose, a cloud-based qualitative analysis program.

After the coding was complete, reports were generated for each top-level code (theme) and for some secondary codes. Each report was reviewed by one or more study team members and more comprehensive and diverse themes were further divided into sub-themes. Narrative under each theme or sub-theme was then classified into sub-codes and each sub-code was assigned a prevalence score based on the frequency of responses that fit the sub-code. This process is illustrated in Figure 2.

Translational Strengths at OHSU: Methodology

Analysis Methods

2013

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Sample Size » Although adequate

for a single group, the STINT sample may not represent all sub-groups of OHSU translational researchers.

Sample Selection » Sample selection

processes favored well-funded, established researchers and high-level research leadership

Methodology Limitations

Translational Strengths at OHSU: Methodology 2013

Coding Report Generation

Identification of Sub-Themes

Classification of Sub-Codes

Assignment of Prevalence

Scores

FIGURE 2: QUALITATIVE ANALYSIS PROCEDURES FOR STINT

The assignment of prevalence scores assists with prioritizing sub-codes. In addition, it provides a visual display that appeals to a wide range of audiences. To assign the prevalence scores, responses under each unit of analysis (theme or sub-theme) were roughly divided into quartiles. Sub-codes with only one response were aggregated into an “other” sub-code. Reduced data was used to populate matrices, a common form of visualization for qualitative data. (11,12). There are four components to the matrix template: a list of sub-codes, prevalence scores for each sub-code, examples of terminology associated with each sub-code, and a sample of selected quotes. Due to reporting constraints, quotes were not illustrated for all themes.

Numbers of study participants responding to each sub-code are included in the legends under each matrix and occasionally within the text. The inclusion of numerical values in qualitative analysis and presentation is, however, controversial. (9,10) Unlike a survey, the denominator of responses varies across codes, themes, sub-themes, and sub-codes. Although all topics were presented to all interviewees, all codes were not. For example, if 10 respondents list a particular barrier, it does not mean that the other study participants don’t perceive it as a barrier. It only means that they didn’t mention it. Numerical prevalence scores, therefore, cannot be compared across themes or viewed as percentages of the total sample.

Finally, a few themes were identified as appropriate for combined analysis. For example, a data table showing referrals by department might be visually aggregated with a network map that shows the origins of those referrals, a matrix highlighting the prevalence score of related disciplines, and an illustrative quote. Themes targeted for combined analyses were selected by the study team based on available data, preliminary analysis results, and anticipated stakeholder interest. From these themes, two data stories were selected that highlight particular areas of strength, illustrate the complexity of the translational landscape, and reflect on barriers.

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Translational Strengths at OHSU: Results

resulTs51 translational researchers & research leaders interviewed

134 researchers received at least one

referral from a peer

247 total referrals to translational researchers made by interviewed investigators

41 organizations represented

2013

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resulTsTranslational Definition

Translational Definition Themes

Classic Bench to Bedside » From scientific

discovery to a specific disease process

» Transfer of knowledge into improved patient care

» Move into humans, not rats or mice

Specific Outcome » Clinical trials » Product to market » Population or

community

Intent » Intent of seeing the

work translated » Basic science that has

potential » Thinking about

impacting human disease

Identifying and defining the scope of what is considered “translational” research has been an ongoing challenge for biomedical researchers and their supporting institutions. The traditional model of “bench to bedside” has been challenged in both scholarship and practice (13,14), and is often confused with clinical research. Although the construct of translation is consistently recognized as a spectrum, opinions vary as to whether or not basic research, community-based research, or policy research should be considered part of the spectrum. At present, OCTRI serves researchers across the broader spectrum with no definitional constraints.

As an organization with a mission to support translational research, OCTRI needs to be aware of how its constituents define the construct. If, for example, the majority of researchers define translational as including policy impact, OCTRI would need to consider whether or not its strategic direction is aligned with the needs of that customer segment. From a methodological perspective, understanding respondents’ beliefs about translation and its meaning can be helpful in interpreting responses to inquiries about strengths and barriers.

How do you define translational research?

Each STINT study interviewee was asked to define translational research. The purpose of the question was not to debate or derive a standard definition, but to solicit a range of responses, identify themes, and classify the results. Responses also provided context for subsequent narrative.

Translational Strengths at OHSU: Translational Definition 2013

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Classification of qualitative responses to the question of translational definition resulted in nine sub-codes from which three main themes emerged. The most prevalent theme was the classic definition of translational research, “bench to bedside.” Over half the responses fell under this theme. Other terminology applied to this definition were the terms “patient care” and “human impact.” Although basic scientific discovery is not excluded from this definition, it assumes that all underlying science will have tangible impacts on humans. For example, one respondent stated, “Translational research is patient-related research whether basic science or epidemiology, it doesn’t matter.” Another summarized, “Everything from taking something from benchside in the lab to the bedside in the hospital.” While the majority of these responses espouse a linear approach to the phases of translation, a few respondents recognize the inherent bi-directionality of translation. For example, another researcher believed that translational research can be “bench to bedside as well as taking gaps in knowledge as a result of clinical [experience] and going back to the laboratory.”

Other researchers proposed more specific, narrower definitions of translational research. “Clinical trials,” “product to market,” and “community” are sub-codes receiving a label of mid-prevalence (~10 respondents for translational definition). For some respondents, clinical trials are an endpoint for translational research. One investigator stated, “[Translational] is taking a basic science concept all the way to a clinical trial.” For others, translational research that extends into the community goes beyond the clinical trial to impact public health. For example, one respondent stated, “Translation is moving from bench to clinical care, from clinical care to office management, and from there to the community.”

Some investigators believe that translational research must result in a marketable product. For example, one researcher states that translational research is “taking something from the lab, where it has no worth, to a product.” Similarly, another responded with, “Develop products. That’s what it is. Products that get on the market. The end point is not another grant, but a product that actually gets used.”

Because the majority of researchers interviewed for the STINT study were designated as either pre-clinical (T1) or clinical (T2) researchers, it is not surprising that the traditional definition (which emphasizes T1 and T2) was the most prevalent and that overt inclusion of community-based and health policy research was less common. However, as noted in later report sections (Results: Demographics and Data Stories), community and policy researchers also received considerably fewer referrals than their counterparts. In fact, two highly funded community researchers selected for the initial sample received no referrals from their peers. This suggests that post-clinical health researchers are less likely to be considered part of the translational spectrum and may be less connected to the OHSU translational research community.

Translational Strengths at OHSU: Translational Definition2013

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Basic Science » Identify the basic

scientists, departments, and projects served by OCTRI

» Consider how support of basic lab science aligns with OCTRI’s goals

Community & Policy » Define OCTRI’s role in

supporting community, health, and policy research

Define Translational to OHSU Leadership & Community » Select a definition of

translational and use it consistently when discussing resources and outcomes for translational research

The third theme under translational definition has a low prevalence score. The sub-code terminology for this theme is “potential” or “intention.” A few researchers referred to the intent to translate as an indicator of translational research. This definition is important because theoretically it encompasses the entire universe of biomedical research. As one investigator put it, “Everything here at OHSU is translational because we are thinking about how we could impact human disease.” The existence of this definition is not a new finding, yet it continues to pose important questions for an organization charged with providing leadership for translational research. At a definitional level, is simply thinking about human impact enough to classify research as translational? Should a time frame for clinical application be applied to discovery research in order to classify it as translational? At an organizational level, how can we (or should we) respond strategically to meet the needs of investigators who are self-identified basic scientists, but whose work may “potentially” impact humans? The two quotes below address the importance of not only defining what translational research is, but also what it is not.

“It’s much easier to answer what translational research isn’t. It’s more than just being able to write a significant statement that makes reference to a human disease. It needs to have a real, tangible parallel to human application. It’s become such a wastebasket term that it has lost its value. I am forcing myself to focus back down again on what translational research means. Is there any theoretical way that the study you’re doing could be done in a human being? It’s not translational research because you said it was.”

“Historically the first idea of translational research was stuff that was grounded in basic science but had clear and predictable potential for clinical revelation. Straight clinical was not included, pretty basic science was not included. Comparative biology was not included. Then the CTSAs got into it and said, ‘That’s not enough,’ then we got into T1 – T4, outcomes delivery, etc. None of that stuff was originally translation. Outcomes research is not bench to bedside. To say, ‘Let’s look at translation,’ you might as well say, ‘Let’s look at research, period.’ Why say translation? You might as well say ‘Research at OHSU’.”

Translational Strengths at OHSU: Translational Definition 2013

“

”

The issue is, if you don’t have something to translate, translation will result in nothing.

24


resulTsDemographics

Key Demographic Results

Study Participants » Both interviewed and

referred researchers have higher average funding levels than the OHSU investigator pool.

» Some referrals may have been made by reputation

Translational Axes » Community & policy

researchers = 14% of sample

» Although this group is small, their funding averages are comparable to T1/T2

OCTRI Involvement » 71% of participants

were PIs or CO-Is on a project receiving an OCTRI service

Translational Strengths at OHSU: Demographic Results

Who did we talk to?

47 translational researchers and four research leaders were interviewed for the strengths study, representing 24 different departments, divisions, institutes, and other entities at OHSU. The resulting list indicates significant coverage of the OHSU research landscape. An additional 90 researchers were referred to the study through the snowball sampling process but were not interviewed due to time and budget constraints. Interviews were concluded when referrals began to repeat and when the target sample size was exceeded.

All interviews were completed within a three month period, and only two contacted investigators declined to participate in the study. Tables 1a through 1c illustrate basic statistics for three groups, interviewees, those receiving referrals but who were not interviewed, and the total pool of OHSU investigators. Table 1a indicates that interviewed subjects had significantly higher funding levels than either the referral-only researchers or the total investigator pool. This is an artifact of the selection process for the initial sample of 10 researchers (20% of total interviewees), which ranked investigators by funding levels. The referral-only subjects, however, also had significantly higher funding levels than the overall pool.

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Table 1a: Grant Funding and IRB Score for Study GroupsInterviewed Referral-only Funded PIs at OHSU

Five-year Grant Funding Total (Average within group)

$8,689,000 $4,279,000 $1,459,000

IRB Score 1.27 1.4 1.25Total Count 47 90 1416*Five-year funding period is FY08 – FY12IRB score is the percent of PI grant projects with an IRB as follows: 0%=0, 1-49%=1, 50-99%=2, 100%=3Source of OHSU funded investigators is OHSU grants data, FY08 to FY12, with some grant types removed

Table 1b illustrates funding levels and IRB scores by primary research approach/translational axis designation. As mentioned, translational axes were assigned to interviewed researchers by the study team, with the understanding that translational models and definitions are both complex and dynamic and that identifying translational researchers of any type is a challenge. (9) Pre-clinical, or T1, researchers represent the largest group of interviewees, followed closely by T2 (clinical) and then community. Community and policy researchers (T3/T4) were combined into one group. Four subjects were classified as research leaders. Although some interviewed research leaders have research portfolios, they were interviewed primarily as leadership and their funding was not totaled. As expected, clinical researchers (T2) had the significantly higher IRB scores than pre-clinical (T1). Although there is a slight drop in IRB scores for community and policy researchers compared to the other two groups, this difference is not significant.

Average five-year funding levels were similar for all three translational groups. Although funding totals for the T3/T4 group appear considerably higher than that of the other two groups, this difference is not statistically significant. This comparison does indicate, however, that community and policy researchers are important contributors to the research landscape.


This suggests that interviewees were more likely to refer to peers with high funding levels. Highly funded researchers probably received some of these referrals based on recognition and reputation. This result has important implications for interpretation of the results, as more established investigators may have different opinions on strengths and barriers than their less established colleagues. Table 1a also shows the IRB score for each group. Derived by the study team from the IRB flag present in OHSU grants data, the IRB score assigns a number to each investigator based on the percent of their projects requiring IRB approval. The score for the referral-only group, (1.4), is slightly higher than that of the interviewed group (1.27) and the total pool (1.25), although this difference is not statistically significant. This indicates that translational portfolios of the interviewed and referral-only groups do not widely deviate from the entire group of funded investigators.

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Table 1c: OCTRI Involvement of Interviewees* (n=51)N %

OCTRI Affiliated Researcher 3 6%OCTRI Project PI or CO-I 36 71%Mentor or Scholar* 21 41%PI or CO-I on OCTRI Pilot Project

23 45%

*The OCTRI scholars program supports early career researchers through mentoring and educational opportunitiesSource of OCTRI participation is OCTRI internal data

As part of the interviews, investigators were asked about their opinions of OCTRI. To help frame responses, OCTRI participation data were obtained for interviewed researchers. Overall, the study sample shows a high level of OCTRI involvement. Seventy-one percent of interviewed researchers have been principal investigators or co-investigators on a project that received an OCTRI service, 45% have been recipients of OCTRI pilot project funding, and 41% have been an OCTRI scholar or a mentor of an OCTRI scholar. Three OCTRI-affiliated investigators participated in the study.


Table 1b: T-axis, Grant Funding and IRB Score for Interviewees*Pre-clinical (T1) Clinical (T2) Community & Policy

(T3/T4)Five-year Grant Funding Total (Average within group)

$8,504,000 $8,062,000 $12,996,000

IRB Score 0.81 1.83 1.43Total Count 22 18 7*Five-year funding period is FY08 – FY12, T-axis designations assigned by study teamIRB score is the percent of PI grant projects with an IRB as follows: 0%=0, 1-49%=1, 50-99%=2, 100%=3Source of OHSU funded investigators is OHSU grants data, FY08 to FY12, with some grant types removed

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Translational Strengths at OHSU: Referrals

resulTsReferrals

Key Referral Results

Translational Strength » ONPRC, the Knight

Cancer Institute, and the Dept. of Family Medicine had the highest % of investigators receiving referrals - indicating translational strength & reputation

Translational Environment » High percentages of

internal referrals may indicate the presence of translational peers & a translational environment, as well as a possible translational silo

In addition to the 51 interviewed subjects, 90 OHSU translational researchers received referrals from their colleagues, but were not interviewed (referral-only). The final referral network contained 141 OHSU investigators. Many researchers received more than one referral, resulting in 257 total referrals. Referrals were analyzed by investigators’ home organizations.

Figure 3 lists all organizations with at least one referred researcher. In Figure 3, the length of the bar represents the total number of researchers within each organization; circles represent the number of researchers receiving referrals from their peers. Because interviewees were asked to refer the study team to translational researchers, organizations with a high percentage of referred faculty can be considered translational strengths. Organizations with lower percentages of translational referrals may still have strong translational portfolios, perhaps filling a unique niche. Translational researchers practicing in these environments, however, may feel more isolated and have less support from translational peers. Again, however, it is important to note that referrals may be influenced by organizational and investigator reputation.

Who is a translational researcher?

Of the researchers receiving the most referrals, one was a self-identified basic researcher who declined to participate in a study of translational research. Two highly funded community researchers from the initial contact list received no referrals. These results indicate continuing ambiguity about the definition of translational research and its local landscape.

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Rural Health

Medicine: Arthritis & Rheumatic Diseases

Center for Evidence Based Policy

Moore Institute for Nutrition and Wellness

Advanced Imaging Research Center

Medicine: Gastroenterology & Hepatology

Emergency Medicine

Medicine: Nephrology & Hypertension

Dermatology

Family Medicine

Medicine: Endo/Diab/Clin Nutrition

Medical Informatics & Clinical Epidemiology

Cell and Developmental Biology

Vaccine and Gene Therapy Institute

Molecular & Medical Genetics

Public Health & Preventive Medicine

Medicine: Pulmonary & Critical Care Medicine

Molecular Micro/Immunology

Administration

CROET

Psychiatry

Biochemistry/Molecular Biology

Surgery

School of Dentistry

Medicine: Cardiology

Anesthesiology

Physiology & Pharmacology

Obstetrics & Gynecology

Otolaryngology & Head/Neck Surgery

Biomedical Engineering

Behavioral Neuroscience

Oregon National Primate Research Center

Vollum Institute

Ophthalmology

OHSU Knight Cancer Institute

Neurology

Pediatrics

Total Investigators in Department Count of Investigators Referred to

FIGURE 3: COUNT OF INVESTIGATORS RECEIVING

REFERRALSBY DEPARTMENT

Green bars indicate departments with more than 20% of researchers

receiving a referral

*Total investigators includes PIs with funding in FY2008 - FY2012

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Figure 4 illustrates referral diversity — in other words, were researchers referring primarily to colleagues within, or outside of, their own organization? Twenty of the 51 interviewees made 100% of their referrals to peers outside their home organization, while five subjects made internal referrals only.

FIGURE 4: REFERRALS OUTSIDE OF HOME ORGANIZATION

Table 2 lists the five departments with the highest rate of internal referrals. A high rate of internal referrals indicates the presence of translational peers within departments, an additional indicator of translational strength. It may also indicate, however, that these organizations are more siloed and are less likely to be aware of or interact with translational colleagues in other organizations. A limitation of the data, however, is the number of interviewed researchers. For example, although Table 2 shows Otolaryngology & Head/Neck Surgery as having a high rate of internal referrals, the study team was only able to interview two of its translational researchers. An investigation into the translational composition of OHSU organizations and the resulting effect on translational culture and actual collaboration should be considered a direction for future research.

Table 2: Departments with High Rates of Internal ReferralsTotal referrals

from inv. in this org.

Referrals to own org.

% internal referrals

Otolaryngology & Head/Neck Surgery 7 5 71% OHSU Knight Cancer Institute 35 20 57%Medicine: Cardiology 14 8 57%ONPRC (Primate Center) 18 10 56%Neurology 10 5 50%

0 5 10 15 20 25

100%

50-99%

1-49%

0%

% of external referrals, by # of interviewees

Seven OHSU researchers received five or more referrals. Six of these investigators have established translational research portfolios. One investigator, however, when contacted and asked to participate in the project, declined by stating that they only do basic research. No community or policy researchers received five or more referrals. In fact, two community researchers from the initial contact list of 10 highly funded investigators received no referrals from their peers identifying them as translational researchers. These results illustrate the ongoing confusion regarding the definition of translational research and the identification of translational researchers.

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To illustrate to/from referrals, all connections between investigators were plotted on a circular network map. Figure 5a shows the connections in their entirety, with each investigator as a node and with organizations differentiated by color. Organizations were roughly grouped (when possible) by relatedness of scientific disciplines. Not surprisingly, the circular network with all connections shown is too dense to distinguish prominent or isolated sub-groups or draw meaningful conclusions.

In order to improve usability of the network map, the map was reduced and redrawn to highlight specific referrals. The adjoining illustrations feature the two organizations with the highest percent of investigator referrals.

Figure 3 showed that both ONPRC and the Knight Cancer Institute had high rates of referrals. There were 24 referrals to 11 ONPRC researchers and 44 referrals to 15 Knight Cancer Institute researchers. Figure 5b shows all referrals from included OHSU organizations to ONPRC, and Figure 5c shows referrals to the Knight Cancer Institute. Although researchers from a range of organizations made referrals to ONPRC investigators, no referrals were made by participants from the Knight Cancer Institute and vice versa. This is notable in that the Knight and ONPRC are two of the largest groups of translational researchers on campus and both were identified by interviewees as translational strengths. This indicates a possible opportunity for improvement in connectivity and sharing within the translational community at OHSU (see additional report sections, Results: Strengths & Data Stories).

Translational Strengths at OHSU: Referral Results2013

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ON

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Knight Cancer Institute




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Medicine: Endo/Diab/Clin NutritionMoore Institute for Nutrition and Wellness



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FIGURE 5a: All Connections

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FIGURE 5b: Referrals to ONPRC

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FIGURE 5c: Referrals to Knight Cancer Institute

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resulTsStrengths & Opportunities

Types of Translational Strengths at OHSU

Scientific Disciplines » Cancer, Neurology

received the highest prevalence scores for current translational strengths

» Cardiology received the highest prevalence score for emerging strength

Organizations » ONPRC is a unique

translational strength at OHSU

Culture » The small size of

OHSU encourages collaboration and collegiality

Having established a working definition of translational research, participants were asked, “What do you think we do well here?” Prompts covered topics such as scientific disciplines, research processes, and institutional culture. Participants were asked about emerging strengths, phrased as “areas we should keep our eye on” for future investment.

The first set of responses encompassed strengths in scientific areas or disciplines. An additional column, “emerging prevalence” was added to the data reduction matrix. Eleven scientific areas were assigned current strength and emerging strength prevalence levels. Of the 11 areas, four were more likely to be mentioned as a current strength than an emerging strength, three were listed only as current strengths, three had equal prevalence scores for both categories, and one discipline had a higher score for emerging than for current. Six additional areas were mentioned by only one or two respondents, and were listed as other. Research areas were labeled and classified based on responses, resulting in some overlap (e.g., stem cell, gene therapy).

Table 3 shows the full data reduction matrix for strengths in scientific areas. High prevalence scores were assigned to strengths sub-codes receiving more than 10 responses.

What do we do well here?

Strengths results were classified into three thematic areas: scientific areas or disciplines, organizations (departments, institutes, centers), and culture.

Translational Strengths at OHSU: Strengths & Opportunities 2013

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Table 3: Scientific Disciplines: Strengths and/or Emerging Strengths

StrengthPrevalence

Emerging Strength

PrevalenceExamples*

Cancer l lCancer, oncology, Knight, Druker, Leukemia, Prostate, Gleevec, Breast (emerging), Cancer

biology (emerging), Pancreatic (emerging), cancer retreats/translation, pipeline, multi-

disciplinary, Tom Beer, Joe Gray

Neurology/Neuroscience l l

Behavioral neuroscience, MS, Stroke, Parkinson’s, Brain Institute, blood-brain

barrier, neonatal brain injury, neuro-degeneration, neuro-protection, adult neuro, neuro & cancer (emerging), neurophysiology

(emerging), Vollum (emerging), Addictions & Alcohol (emerging)

Genetics l lGene therapy & trials, genomics, genotyping,

epigenetics, ocular & opthalmic genetics, gene regulation, genetic counseling, genetics

ethics

Stem Cell l l Shoukhrat, Grompe, ONPRC, developmental origins (emerging), cell therapy

Ophthalmology l NoneCasey, gene therapy, algorithms, Neuro-ophthalmology, pediatric opthalmology,

imaging, ocular & ophthalmic genetics

Outcomes/Evidence-based, Community-based l l

Outcomes based research, evidence-based, practice-based, ORPRN, John McConnell,

CHSE

Cardiology l l Cardiology, Knight Cardio, heart valve, multidisciplinary, micro-bubbles (emerging)

Vaccine Research l None Vaccine, VGTI

Hearing l l Hearing, Paul Flint, VA, Translational

Diabetes l l Obesity, diabetes, chronic disease, diabetes center, child + adult (unique)

Rare Disease l None

OtherImmunology, Pediatrics, Endocrinology, Ep-idemiology, Dermatology, Infectious Disease

(emerging), Microbiome (emerging)*For scientific disciplines, names of investigators were included as examples when participants mentioned these names as locally synonymous with the specific discipline.

Legend: High Prevalence Mid to High Prevalence Mid Prevalence Low Prevalence

l l l l

Respondents > 10 7-9 5-6 2-4

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Translational Strengths at OHSU: Strengths & Opportunities2013

Six disciplines received a “current strength” prevalence score of high or mid-high prevalence. These fields are well recognized at OHSU for their contributions, yet for each area at least one conditional statement was made. For example, an area might have received recognition simply because of a single star researcher. Others have large numbers of associated faculty or external funding, but their scientific impact is less clear. These discrepancies complicate the certainty of identifying an area as a translational research strength. While researchers’ thinking about what constitutes a strength was diverse, their reasoning tended to stratify into five distinct dimensions. Analysis of narrative data exposed recurring areas within each dimension and inspired the creation of Table 4, a proposed framework for evaluating potential strengths. Although thresholds for confirming an area as currently strong will differ across organizations, disciplines that contain elements of all five dimensions may be considered translational research strengths, while those that contain fewer dimensions and/or elements may be considered emerging strengths. This framework can be used informally or aligned with a more rigorous data gathering and evaluation process. OCTRI, for example, may wish to highlight unique strengths in its response to the NCATS RFA. In considering service provision, however, OCTRI may wish to discover scientific areas with a high penetration of early-career researchers. The framework provides a way to consistently and methodologically define and identify strengths in scientific disciplines.

Table 4: A Framework for Evaluating Scientific Strengths in Translational ResearchLeadership People Funding Culture Outcomes &

ImpactScientific leadership

Research stars High external funding $$

Multidisciplinary Traditional: publications, new funding

Organizational leadership

Critical mass of researchers

High level of institutional support

Translational External recognition

Leadership support from institution

Diversity in career stages of researchers

Diversified funding stream

Collaborative Impact, reproducibility

Community, network, extra-mural support

Large #s of patients

Generally high likelihood of sustainability

Unique/highly focused

Non-traditional, alt-metrics

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Translational Strengths at OHSU: Strengths & Opportunities

Attempts to solicit or uncover areas of emerging strength were less successful than anticipated. The process of inquiring about emerging strengths was more likely to result in qualification of previous comments about strengths and only one research area received a mid prevalence score for emerging (cardiology). As mentioned, predicting emerging research areas is a formidable task. In an environment of shifting strategic direction and unstable funding, investigators may be hesitant to speculate on future directions outside of their own research.

The second category of strengths involved OHSU organizations such as departments, institutes, and centers. The organizations discussed in this section were purposefully distinguished from scientific disciplines (discussed above), as these entities received interviewee recognition for more diffuse reasons including researcher education, collaborative efforts, successful affiliations, and overall uniqueness. This category included a (very) few references to infrastructure and cores. The organization with the highest prevalence score was ONPRC (Primate Center). Examples of terminology associated with ONPRC in the analyzed narrative include: stem cell, diabetes, imaging, pharma, toxicity, gene therapy, neuro, and reproductive. These tags are not unique to ONPRC, but were mentioned by investigators referencing the Primate Center. Other themes tagged in reference to ONPRC include: translation, public relations, and the ONPRC-OHSU relationship (with the latter two themes listed as challenges). ONPRC stood out among respondents’ narrative as a strength that is unique to OHSU. For example, one researcher stated, “OHSU is poised like no one else because we have the national primate center.” Other descriptors included “astounding” and “exceptional.”

Other organizations receiving mid-high or mid prevalence scores were OCTRI Education, OCTRI (overall), and Biomedical Engineering (emerging). Organizations receiving one to three mentions each included: CAHMI, the VA, CROET, the Nutrition Center, PATH, Women’s Health, and Family Practice.

A limitation, or caveat, to the interview results on identification of strengths in scientific disciplines or campus entities is the tendency of subjects to profess their lack of knowledge about activities outside their own research area. More than half of the interviewed researchers made at least one comment referencing their relative isolation. For example, one scientist stated, “I don’t know what others are doing. I can’t keep up. We’re all so busy and brains can only hold so much information. A lot of people here talk about this or that I haven’t heard about. Sometimes emails just get lost. You have to pick and choose what you can handle.” This result seemed particularly prevalent for cancer researchers. Of the seven researchers interviewed whose research is primarily in cancer, six made statements about their lack of ability to accurately assess translational activity outside of their field. As one cancer researcher stated, “All I think about is cancer, it’s all I do. I can’t address anything else.” In addition, researchers whose home department is the Knight Cancer Institute made 57% of their referrals within their department (the second highest internal referral percentage).

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Translational Strengths at OHSU: Strengths & Opportunities

The Knight Cancer Institute is a clear translational strength, both in sheer numbers and in translational culture. In addition, many biomedical research areas are at least tangentially related to cancer. However, it is likely that cancer researchers could benefit from expanded knowledge of the work of their translational peers. In addition, non-cancer translational researchers could benefit from lessons learned in the Knight about translational processes and culture. For example, several Knight researchers mentioned the success of cancer retreats as facilitating basic and clinical interchange, “clinicians can ask scientists questions, scientists can ask clinicians questions.”

The final category of strengths was culture. Four areas of strength were identified under culture: collaboration and collegiality, culture of discovery, size, and accessibility of physician-scientists. Collaboration received the highest prevalence score, eliciting comments such as, “People are willing to work with new people, to pull together and make younger scientists successful,” and “Some of the structural strengths are, it seems to be a pretty easy place for interdepartmental relationships and teams to form and self-assemble. This happens pretty well here. It’s more than collegiality. The university gets out of the way.”

The small size of OHSU was also mentioned by a few participants, “a strength is that OHSU is a small and dynamic place. You can capitalize on knowing what other people are doing.” Although this construct overlaps with collaboration, it is worth calling out specifically as small size is more often seen as a barrier. More interesting, however, is the contrast between the emphasis on collegiality and collaboration and the tendency of study participants to profess their limited views of others’ work.

Other strengths mentioned that don’t fit well under the three main sub-themes include OHSU’s credibility in the community and strengths in discovery and clinical trials. Discovery strengths mentioned include the Vollum, imaging, pre-clinical (generally), and “moving ideas through relevant animal models”. Clinical trial strengths were mentioned in connection with the Casey Eye Institute and the aggregated scientific discipline of Rare Diseases.

Several respondents highlighted the existence of OHSU’s physician-scientists as a strength. Although there are considerable barriers to successful navigation of the basic to clinical pipeline, as well as to collaborations between basic and clinical researchers (Results: Barriers), physician-scientists are key contributors to translational research. One interviewee described them as “the glue that makes translation work,” adding that, “if you only have PhDs and physicians it is hard to build a translational enterprise.” Physician-scientists are viewed by many interviewed researchers as bridges, or boundary-spanners (Results: Translational Funding Priorities). Boundary spanners are workplace leaders who can bridge boundaries among groups with different values and priorities, while addressing a larger organizational vision. (15) Boundary spanners can impact translational research by traversing the translational spectrum with their own research, by connecting basic and clinical researchers, and by encouraging trans-disciplinary science.

2013

39


Recommendations for OHSU and OCTRI

Use Consistent Methodology to Identify Strengths (Table 4) » In conversations about

research strengths, OHSU & OCTRI leadership should use a Strengths Framework, such as the one in this report, as a guide

Promote Collaboration & Collegiality » Capitalize on the

small size of OHSU to maximize meaningful collaboration and communication, integrating both cancer & non-cancer research areas

The majority of translational opportunities occur through the catalyzation of strengths and the overcoming of barriers. Suggestions for OCTRI and OHSU can also be viewed as opportunities. The STINT study team did, however, code for a few translational research opportunities that were not covered extensively elsewhere. Distinctive themes under opportunities were team science, cross-institutional work, and care delivery. Team science was presented by a few interviewees as an opportunity for new funding, theorizing that the chance of obtaining funding is higher with multiple principal investigators. Perhaps as a result of new funding, team science was also presented as an opportunity to solve real-world problems, to provide stability for young scientists, and to move scientific silos closer together.

Several researchers mentioned opportunities for cross-institutional work with local partners such as Portland State and Oregon State, community networks, and industry. Two care delivery opportunities mentioned include working with Coordinated Care Organizations in Oregon and implementing OHSU incubated research in OHSU clinics.

Translational Strengths at OHSU: Strengths & Opportunities 2013

“

”

Here, we’re big enough that we can make a difference, but small enough that there aren’t too many competing interests.

41


re s u lTsBarriers

Examples of Barriers to Translational Research at OHSU

Funding & Time » Declining research $ » Constrained local

funding options » No time for translation

Infrastructure & Cores » TTBD is underfunded » IRB — “culture of no” » Lack of GMP, GLP » Contracting is slow » Trend to “build your

own”

Leadership » Mistrust between

research and hospital » OHSU goals are too

broad, not transparent

Communication » Lack of time, tools,

and opportunity for information sharing

Study participants were asked about barriers to conducting translational research at OHSU. All participants addressed one or more barriers, resulting in the five sub-themes listed above as well as an extensive list of sub-codes and examples. Within the theme of financial resources, three sub-codes received high prevalence scores. The first sub-code referred to the general decline in available funding for biomedical research. Examples of worrisome trends include the increasing difficulty of getting an R01, the effects of sequestration, and declining dollars for basic research. One investigator stated, “To stay employed in the R01 world, you have to carry four or five R01s, you are always writing a progress report or writing a grant application.” The limited availability of local funding options also received a high prevalence score under barriers. Local funding options referenced include institutional bridge funding, departmental support for physician-scientists, and OCTRI pilot grants. Also included in this category were expressed frustrations regarding overhead policies and cost structures for K awards. A few investigators mentioned the funding constraints faced by CTSAs as a barrier to adequate resources for translational research.

What makes it hard to do translational research here?

Barriers were categorized into five sub-themes: financial resources and time available, infrastructure and cores, OHSU leadership, communication, and demographics.

Translational Strengths at OHSU: Barriers 2013

42


Translational Strengths at OHSU: Barriers2013

Limited time is also a considerable barrier, receiving a high prevalence score. Interviewed investigators wish they had more time for research in general, grant writing, and collegial engagement. Investigators also commented specifically on the time commitment needed for translational research, “The real barrier is people’s time and fear that translation is a sink of their time and that it can be a career killer.”

The second category of barriers included references to infrastructure, cores, technology, and commercialization. These are all things that affect the speed and success of clinical research. Researchers provided examples of research support services that are perceived to be overly risk-averse and/or too slow, procedures that make it difficult to participate in multi-institutional projects, or cores that are expensive and/or underfunded. Table 5 lists internal infrastructure barriers. High prevalence scores were assigned to barriers sub-codes receiving more than 10 responses.

Table 5: Internal Barriers to Translational Research

Sub-code BarrierPrevalence Examples

TTBD lInconsistent, Risk-averse, underfunded, understaffed, lack of transparency, lack of expertise, slow, multi-institutional

projects are difficult

IRB l Risk-averse, forms/maintenance difficult, slow/burdensome, multi-institutional projects difficult

Cores need improvement lInformatics, biostatistics, analytics, immunohistology,

pharmacokinetics, endocrine, general lack enough funding for existing cores

Technology needs improvement l

ITG, computation, EPIC (for research), high throughput screening, data management

Contracting, Grants & Contracts l

Slow, risk-averse, multi-institutional projects difficult

Space l Co-location needs not met, clinic space for research lacking

Lack of GMP/GLP l GMP, GLP: need generally as a resource

Other regulatory, FDA, IND l FDA, IND, lack of expertise, need more help with paperwork & red tape

Other clinical trial barriers l General infrastructure for clinical trials is lacking, skill sets still needed, lack of patient base

Tissue acquisition l Not a system, based on relationships

Faculty l Need for “boundary spanners,” translational faculty, shared faculty positions


l l l l

Respondents > 10 7-9 5-6 2-4

43


Examples of core barriers include Tech Transfer and Business Development (TTBD) and the Institutional Review Board (IRB), both with high prevalence scores. Referring to TTBD, one investigator stated, “One [barrier] is business development, it is understaffed, underfunded, under appreciated. They are going to really have to have more people. They need authority and activities to integrate scientists into the pipeline.” In addressing IRB barriers, another researcher stated simply, “IRB – culture of ‘no’.” Several researchers mentioned barriers due to contracting, particularly in regards to turnaround time, risk-aversion, and lack of expertise in dealing with multi-site contracts. One researcher avoids contracting, stating, “Contracting is slower than it should be, both in reviewing and creating contracts. A lot of people in the first phase of clinical try to side step contracts. We try not to use them because they slow us down.”

Investigators also pointed out areas where they believed there was a lack of expertise or where they believed a key resource was missing entirely. The lack of access to GMP/GLP facilities received a mid to high prevalence score. The sub-code technology received a high prevalence score, aggregating diverse areas such as data management and linking, EPIC searches, and quantification software for high throughput screening. For example, one investigator stated a need for, “data management, understanding measures of health at all levels so we can really know the denominator. Mining practice data, getting hospitalization data, quality metrics data, — a robust data management center.” Other resources referenced as needing improvement include immunohistology, pharmodynamics, and toxicology. The lack of opportunities for co-location was also discussed as a barrier. For example, physical separation of collaborators and potential collaborators can impede the formation and progress of team science.

Infrastructure sub-codes receiving mid or low prevalence scores were specific references to regulatory and FDA support, clinical trials infrastructure, and translational faculty recruitment efforts. FDA red tape and IND paperwork were mentioned as barriers to clinical and translational research. One researcher stated, “The paperwork for IND will keep you from writing an R01 renewal or seeing patients. I can think of three investigators that have said, ‘I can’t run a clinical trial, it will kill me.’” Researchers referring to the hiring of translational faculty emphasized recruitment of boundary spanners – faculty who can cross departments and/or translational stages.

The third category of barriers is leadership. Two sub-codes receiving mid-prevalence scores were “prioritization of clinical work,” and “broadness of institutional goals.” The former refers to an ongoing tension that is common within academic medical centers — the confluence of the health care, research, and education missions. Some interviewed researchers believe that hospital leadership controls institutional priorities and that researchers are not viewed as valuable or viable contributors. Hospital leadership references made by interviewees were relatively acerbic, ranging from, “The hospital values research primarily when someone else pays for it,” to “The relationship with the hospital is horrible.” Several researchers also believe that translational research is not a priority for leadership, even among those who generally support the research mission.

Translational Strengths at OHSU: Barriers2013

44



Internal Funding » Increase diversity and

availability of internal funding options for translational research

Support for Multi-institutional Projects » Address TTBD,

contracting, and regulatory barriers to improve facilitation of cross-institutional projects

“Bridge the Gap” » Increase trust and

communication between basic and clinical researchers and between the hospital and research elements of OHSU

Another thread of concern under leadership is that of peanut buttering. This term refers to the idea of spreading resources too thinly. At least six interviewees believe that institutional goals are too broad and that leadership avoids making tough decisions about what the institution will not support. As one investigator put it, “They’ve tried to do a little bit of everything. They haven’t ever said we need to not do some things. They’ve never done that. They’re not going to be able to have centers of excellence until they do that. When money gets tight, they cut everybody instead of making hard decisions. Nobody wants to make those decisions.” A few subjects reported feeling that high-level decision-making processes are opaque and based on current trends rather than an overarching vision.

Sub-codes under leadership barriers that received low prevalence scores include a lack of quality branding and public relations for the research mission and the relatively low impact of time-consuming quality improvement efforts.

The fourth sub-theme under barriers is communication. As a barrier, communication issues generally received mid or low prevalence scores, but are worth noting for their interactions with other topics. For example, although investigators are generally willing to collaborate (Results: Strengths), they also mention difficulties in finding and connecting with potential collaborators and making time to share resources and information. The small size of OHSU is also considered a strength (Results: Strengths), yet a few researchers believe that separation among campuses restricts communication and collaboration. Limited communication between clinical and basic departments and between clinicians and basic scientists was also a barrier mentioned by a few investigators. As one participant stated, “The biggest problem that I see is that the basic science departments don’t talk to the clinical departments. Do not do. It’s not done culturally.”

The final sub-theme under barriers further addresses OHSU demographics, considering the small size and location of OHSU as a barrier as well as a strength. Demographic barriers mentioned by respondents include difficulty in recruiting minorities, the lack of a full-service university, less “hallway pressure” than might be found at other academic medical centers, and geographic isolation.

Translational Strengths at OHSU: Barriers 2013

“

”

How many times do you hear people on the clinical side saying that research costs us money?

46


re s u lTsTranslational Funding Priorities

Priorities for Supporting Translational Research at OHSU

Infrastructure » Infrastructure for

clinical research and commercialization

Internal Funding » Funding for innovation

& incubation » “Buy” researchers’ time » Funding sustainability

Science » Specific diseases » Complex systems » Community research

Leadership » Investigate best

practices

Recruitment » Translational faculty,

boundary spanners

Interview questions about strengths and barriers elicited a wealth of suggestions for improvements across the OHSU translational landscape. With the intention of prioritizing some of these suggestions, interviewees were offered a fictional grant of $100 million dollars for translational research and asked for their opinions as to how they would spend the funds. Responses were classified into five categories: infrastructure and technology, internal funding mechanisms and sustainability, science, decision-making and leadership, and faculty recruitment. Quotes rather than associated terminology were included in tables for this report section in order to list as many specific examples of suggestions as possible. Although this question was framed as the “fun” question, it was the impression of the study team that responses to this question were well thought out and carefully considered.

Topics covered under this line of inquiry overlap considerably with themes discussed under strengths and barriers. Many researchers agreed that they would use the funds to address some of the barriers from their earlier narrative. Areas of considerable overlap include funding (particularly internal funding options), time for research, and infrastructure resources.

If you were given 100 million dollars to support translational research at OHSU, how would you spend the money?

This question was also phrased as, “If you were the czar of translational research at OHSU, what would you do?”

Translational Strengths at OHSU: $100 Million 2013

47


Translational Strengths at OHSU: $100 Million

The second thematic area of suggestions for investment in translation was internal funding for innovation and incubation. This topic included suggestions around pilot funding, OCTRI funding, OHSU bridge funding, venture capital, and time-based support of researchers. Venture capital funding was suggested as a way to provide funding for commercialization and as a method of putting dollars back into the fund. Giving researchers, particularly young researchers and physician-scientists, time to generate ideas, do research, and “think” was a topic addressed by several interviewees. As one investigator put it, “The excessive urgency for immediate success is a barrier.” A few respondents suggested that they would give additional funding to OCTRI, although these suggestions may be biased given the affiliation of the study team. Table 6b lists selected quotes under funding.

Table 6a: $100 Million for Translational Research Infrastructure

Prevalence Example Quotes

Central Services l “I would use some of the money to recruit some real professionals in tech transfer.”

Clinical Research l“I would invest in the clinical enterprise. I would do an evaluation

of where the roadblocks are so that any clinician who wanted to do a clinical trial could do it now. I would look at staffing at all levels,

clinical trial management, patient evaluation, and the IT to enable it.”

Other Cores l“I still like the GMP thing, but the issues there are huge. They aren’t

going to be busy enough. They don’t have the scale.” “I would build up a really good core system. That’s the way you would

touch more people.”

Physical Infrastructure l“I would design it such that the basic sciences and clinicians were on top of each other. I would build a disease centered program as

opposed to a department.”

Technology l“We don’t use our EPIC database as well as we should. I would

make it easy to query, easy for CROs. How do we use the rest of the community? How do we then use these alliances to increase patient

volume for our trials? The business model has to be solid.”

Receiving high prevalence scores were infrastructure investments that aim to improve the efficiency of clinical trials, enable commercialization, and facilitate communication between basic and clinical researchers. Table 6a lists the sub-codes under infrastructure and technology and includes relevant quotes. Resources that were also mentioned prominently under barriers include TTBD and GMP/GLP (Results: Barriers). As before, researchers were divided as to whether GMP and/or GLP resources should be available in-house or whether availability should be through strengthened institutional partnerships. Clinical trials infrastructure and co-location, listed below, were also mentioned under barriers.

2013


l l l l

Respondents > 10 7-9 5-6 2-4

48


Translational Strengths at OHSU: $100 Million

Table 6b: $100 Million for Translational Research Internal Funding


Innovation and incubation l

“More pilot studies to get young people in.”“I would set it up as a venture fund. We have a perfect point, the BIP pro-

gram...I’m talking about translation at the level of, ‘I need to build this device’ or making GMP quality protein.”

“I’d put more seed grants into people that don’t currently do translation. I’d try to get people out of the corner .”

Funding for research time l

“I think if people really mined the translational landscape here they would find highly promising ready to go projects. Tell faculty, ‘Forget about your R01.

Focus on this. We’re giving you 5 years and that’s what we want you to do.’.”“Carving out time to do clinical trials, when there’s no way to relieve clinicians

of their clinical responsibilities.”“I would buy protected time for physicians.”

In addition to specific funding suggestions, several respondents emphasized the importance of funding sustainability, strong stewardship, and the creation of an endowment with all or part of the funds. As one interviewee pointed out, “It doesn’t take that long to spend 100 million. We at the Knight (Cancer) have run through it already.” Many researchers also mentioned things that they would not spend the money on. One example is “new buildings.” Most interviewees responding to this question preferred that the majority of the money stay in the trenches, with scientists, rather than being spent on oversight and management.

Many investigators mentioned funding research in specific focus areas such as cancer, immunology, or community-based research. For some interviewees, these were their own research areas while others recognized additional translational possibilities at OHSU. Table 6c lists selected sub-codes and quotes. In order to avoid bias toward the research of specific interviewees, quotes were only selected from interviewees who spoke of research areas outside their own area of expertise. In addition to those listed in table 6c, other scientific areas mentioned include vaccine research, global health, rare diseases, cancer, and gene therapy.

The fourth category of translational funding priorities is decision making and leadership. Many interviewees believe that in order to achieve the greatest impact, OHSU research strategy should focus on uniqueness; what currently makes OHSU unique and what could make us unique given the right investments. Operational definitions of uniqueness varied. Examples given by interviewed researchers include purchasing a piece of equipment that allows for unique lines of inquiry or investigating demographics and health care systems that are unique to Oregon.

2013


l l l l

Respondents > 10 7-9 5-6 2-4

49



Augment Clinical Research Infrastructure

» Identify needs

Recruit Boundary-Spanners » Translational

faculty that traverse basic+clinical & departmental boundaries

Be Unique » For greatest impact

Learn About Best Practices » Gather data from other

institutions when considering change

Another strategic tactic mentioned relatively frequently under decision-making was the opportunity to learn from other institutions. Gathering information on successful practices can enlighten and energize processes, saving time, money, and energy. As one investigator suggested, “First I would get on a plane and go to Stanford and MIT and talk to their tech transfer offices and see how places do it that are successful and see how to do it.”

Finally, nine researchers mentioned using the funds to recruit and hire faculty. Investigators referencing faculty appointments mentioned hiring more translational faculty, faculty focused on team science, research “stars,” and faculty who are boundary spanners.

Translational Strengths at OHSU: Barriers

Table 6c: $100 Million for Translational Research Science


Disease l

“One area very developed on the clinical side is Parkinson’s. They have a good clinic, they have surgeons, they have people in engineering and

neuroscience.”“I would fund a clinical immunology center for

immune mediated disease.”“Some diseases are not ready to be translational.”

Exploratory l“There is a huge interest right now in the human Microbiome. There are 10 trillion cells with 100

trillion bacteria that you can’t live without.”“One thing I would do is figure out what we should

do to become a center of excellence in Microbiome.”

Community l“I would get new people on the higher end of the

ladder working on policies, community based researchers, to see a change and get things pushed

into policy.”

Other Science l

“I would identify a couple of areas here where I think there is the basic science that could be taken to create types of treatments that would be useful

in patients. Those areas would be genetics and neuroscience.”

“Would spend it entirely on precision medicine”

2013


l l l l

Respondents > 10 7-9 5-6 2-4

“

”

What’s the best way to make Portland the healthiest city on the planet? We ought to focus on 1 or 2 things that make us unique.

51


re s u lTsOCTRI

Experiences with OCTRI

Strong Leadership » OCTRI leadership

advocates for translational research

Awards are Popular » BIP Program » Awards > $10K

Highly Regarded Education Program » HIP, MCR

Ineffective Public Relations » What is OCTRI’s

strategy? » What is available?

“Build Your Own”

» Departments duplicate resources

Respondents generally had strong praise for OCTRI and credited OCTRI with establishing a translational environment at OHSU. Areas of strength identified by interviewees include strong leadership and the OCTRI education programs (Human Investigation Program/HIP, Master’s in Clinical Research/MCR). Other, more specific commendations were directed towards the availability of pilot funding, the process of defending pilot applications in front of OCTRI reviewers, and the Biomedical Innovation Program. Respondents have successfully utilized Redcap (OCTRI Informatics), biostatistics (OCTRI and SOM supported BDP), and IRB application support (OCTRI Investigator Support Services).

Unfortunately, nearly all interviewed researchers are still confused about OCTRI’s goals, translational territory, and offerings beyond the awards program. As one investigator stated, “The grant dollars I got, I don’t know what they do otherwise.” A few researchers were unclear as to where OCTRI fits on the translational spectrum, with one investigator believing that OCTRI is primarily focused on T2, and that what basic scientists consider translation is getting the “short end of the stick.” Interviewees occasionally expressed confusion about the cost of OCTRI services, with at least one person stating that although they understand OCTRI is “fee for service,” colleagues sometimes get services for free “for unknown reasons.”

What is your experience with OCTRI?

Although the majority of STINT respondents had prior experience with OCTRI as well as general praise, many were unaware of the ways in which OCTRI can impact their research.

Translational Strengths at OHSU: OCTRI 2013

52


Translational Strengths at OHSU: OCTRI

These results are not surprising, given previous anecdotal evidence suggesting limited campus awareness of OCTRI. This particular sample, however, had a relatively high level of OCTRI involvement (Results: Demographics). As noted earlier, 71% of interviewees have been a PI or a CO-I on a project receiving one or more OCTRI services. This discrepancy is perplexing. Possible explanations include the tendency of researchers to link to a particular service and not to OCTRI as a whole, and the distribution of OCTRI award dollars without additional added services.

To some extent, the STINT sample of highly-funded investigators does not find OCTRI relevant to their work. Because the vast majority of interviewees are established investigators with access to financial and other resources, they may be less likely to need OCTRI’s services than younger, early-career investigators who have limited access to continuous funding streams. In fact, a theme coded by the study team was “build your own.” This refers to researchers and/or departments who develop their own, highly localized, resources rather than using a central service such as OCTRI. Interviewees from the following organizations mentioned building their own clinical trials infrastructure: Casey Eye Institute, Cardiology, Dermatology, and Pediatrics. Other researchers mentioned hiring staff or looking for external resources because OHSU and/or OCTRI resources are not efficient, cost effective, or don’t provide the necessary level of expertise. Specific references include regulatory and FDA support. In addition, some departmental resources are duplicative of what OCTRI provides, particularly at the Knight Cancer Institute. One interviewee stated, “The Cancer Institute has a parallel pathway to do a lot of the same things.” Duplicative resources were not always viewed as a negative. Localized resources can result in greater efficiency, allowing core resources to become more specialized.

Because younger investigators are less likely to be able to “build your own,” many interviewees believe that OCTRI should focus on helping early career researchers. As one respondent stated, “Most [young] investigators have never had access to primates or translational research. Those are the ones that would benefit most. If they are 20 years in and still struggling to be successful, they’re not going to be. I would focus efforts on young people. What makes them more competitive for funding? But they’re the quiet ones, it’s all of us senior people who are being responded to.” At least one researcher suggested that helping young investigators should include directing pilot funding to less established or emerging translational researchers.

As mentioned, OCTRI is primarily known for its awards program. Specific suggestions around the awards program include increasing the amount of funding (>10K), so investigators are less likely to simply extend what they are doing with another grant. OCTRI is currently offering larger grants through the Catalyst program, although not all investigators seem to be aware of this opportunity. It was also suggested that OCTRI utilize the award program to incentivize team science. Interviewees expressed disappointment with the Kaiser partnership and the resulting loss of community and cross-institutional connections.

2013

53



Focus on Strategy » Communicate OCTRI

strategy to OHSU » Lead discussions on

OHSU translational strategy

Market OCTRI » Make personal

connections » Disseminate OCTRI

participation data

Identify the OCTRI Non-Customers

» Who isn’t using OCTRI? » Where are the young

investigators?

Implement Suggested Services » Education modules » Research concierge for

potential collaborators and resources

A few researchers believe that OCTRI could benefit from more funding from the NIH and from OHSU. As one researcher stated, “[The OCTRI Director] is very articulate and is a strong advocate, but the institution hasn’t come forward with the resources needed.”

In addition to the suggestions mentioned above, additional suggestions for OCTRI from individual interviewees are listed below:

Communication• Meet with investigators and tell them what OCTRI can do for them• Send a letter to department chairs detailing how their department has benefited from OCTRI each year• Communicate OCTRI’s strategic plan • Communicate OHSU’s strategic plan for translational research — where does OCTRI fit?• Establish OCTRI liaisons to target departments/scientific areas/ portfolios so researchers know who to contact

EducationAlthough OCTRI’s education program has an excellent reputation among study participants, investigators were forthcoming with a few suggestions:

• Use scholarships to recruit translational medical & graduate students• Offer trainings in how to manage grant funds and how to spend remaining funds when the work is completed• Teach basic researchers how to articulate the human impact of their work

As discussed elsewhere in this report, many interviewed researchers believe there is a need for stronger connections among translational researchers at OHSU. Investigators suggested that OCTRI could help make connections, with one researcher suggesting that OCTRI develop a translational research “concierge” service that would connect researchers with each other and with internal and external resources.

Translational Strengths at OHSU: OCTRI 2013

“

”

It enhances OHSU. We wouldn’t be on the map without having a CTSA. We’re in the ‘in’ crowd.

55


re s u lTsData Stories

Community & Policy Researchers

Community & Policy Researchers are Well Funded » Grants data show

funding levels similar to or above T1 and T2 researchers

Community & Policy Researchers are Considered a Strength

» Outcomes, evidence-based, and community-based research received a prevalence score of mid to high

Are Community & Policy Researchers Considered Translational? » As a group, only one

referral from outside T3/T4

As the institutional, referral, and interview data were triangulated, two stories emerged. The first story asks a question about the role of community and policy research in the translational landscape at OHSU. As noted earlier, the study team assigned translational axis labels to each interviewed researcher. Using this process, seven respondents were labeled either T3 (community) or T4 (policy). OHSU grants data show a five-year grant funding total for the combined T3/T4 group at nearly 13 million. Table 8 (duplicate of Table 1b) compares T1, T2, and T3/T4 interviewees. Although the funding differences among the three groups are not statistically significant, the results indicate that community and policy researchers are well funded.

Table 8: T-axis & Grant Funding for IntervieweesPre-clinical

(T1)Clinical

(T2)Community & Policy (T3/T4)

Five-year Grant Funding Total (Average within group)

$8,504,000 $8,062,000 $12,996,000

Total Count 22 18 7*Five-year funding period is FY08 – FY12, T-axis designations assigned by study teamSource of OHSU funded investigators is OHSU grants data, FY08 to FY12, with some grant types removed

Community & Policy Research: A Translational Strength?

Translational Strengths at OHSU: Data Stories 2013

56


Translational Strengths at OHSU: Data Stories

The grants and narrative data illustrate that T3 and T4 researchers are likely impactful — but are they translational? Although community and policy research is clearly included in the translational spectrum (12,13,15), there are indications that STINT respondents do not view their T3/T4 colleagues as translational. Two views of a network graph illustrating referrals among interviewed researchers illustrate the relative isolation of this group from their translational peers.

2013

Figure 6a shows all referrals to and from respondents, while Figure 6b shows referrals only to community and policy researchers. Community and policy researchers referred only to each other, and only one community researcher received a referral from outside of the T3/T4 group. Two members of this group who were in the initial sample of highly funded investigators received no referrals at all. In contrast, a self-described basic researcher who does no translation was one of the most-referred researchers.

As strengths, community and policy research received a narrative score of mid-high prevalence for current strength and low prevalence for emerging strength. The vast majority of the comments around community and policy researchers were made by members of this group. One [T1] investigator stated, “We are strong at outcomes — T4 type stuff.” The same researcher then stated, however, “I know we have a center for evidence based policy but I have no clue if they are good.” Only one other non-T3/T4 researcher spoke of community research outside of a desire to develop community recruitment efforts for clinical research. In defining translational, investigators typically spoke of bench to bedside research. While this definition does not exclude community and policy research, it was rarely called out.

Both the CTSA RFA and the Institute of Medicine report on the CTSAs (1,15) emphasize the importance of including community engagement in all phases of translation, not just as a separate component. As OCTRI moves forward with strategic planning, it will be important to define the role of community and policy research and researchers in the landscape of translation at OHSU and, therefore, the desired degree of OCTRI integration, commitment, and support.

FIGURE 6a: REFERRALS TO/FROM INTERVIEWEES

FIGURE 6b: REFERRALS TO COMMUNITY & POLICY INTERVIEWEES

Research Leaders

Preclinical

Clinical Community

Policy

Research Leaders

Preclinical

Clinical Community

Policy

57


re s u lTsData Stories

ONPRC

Well Funded

» Five-year FY2008 - FY2012 grants data put ONPRC at the top

High Count of Researchers Receiving Referrals from their Translational Peers » 24% of ONPRC

researchers received referrals from their translational peers

The Oregon National Primate Center (ONPRC) figured prominently in all analyses of STINT data. Grants data used for STINT analysis show ONPRC as having the most funding of any OHSU organization over the five year period (FY2008 - FY2012). In addition, ONPRC is second only to the Knight Cancer Institute in numbers of interviewees and subsequent referrals. Figure 8 shows a subset of Figure 3 (shown earlier), which ranks included departments by the total number of investigators (bar), and indicates the number who received referrals (dots). Figure 7 shows departments with referral rates of more than 20%. Similar percentages of investigators received referrals at the Knight Cancer Institute (23%) and ONPRC (24%). These departments can be considered highly translational.

Oregon National Primate Center: A Unique Translational Strength

Translational Strengths at OHSU: Data Stories 2013

FIGURE 7: DEPARTMENTS WITH 20% OR MORE INVESTIGATORS RECEIVING REFERRALS

58


Translational Strengths at OHSU: Data Stories2013

Analysis of interview narrative resulted in ONPRC receiving the highest prevalence score under strengths-organizations. As mentioned earlier, the Primate Center received high praise for its uniqueness and its translational role. One investigator stated, “When you look at OHSU and try to figure out what it’s good at and what sets it apart, it’s really the Primate Center.” In addition, researchers referred to Primate Center work when defining translational research.

A reduction of the referral map originally shown in Figure 5 (Figure 7, below) indicates that ONPRC researchers receive referrals from diverse locations around the university. They also, however, have a high rate of internal referrals (Table 2, Results: Referrals). Fifty-six percent of ONPRC respondents referred the study team to other ONPRC researchers, a ranking similar to that of the Knight Cancer Institute and Cardiology. A high rate of internal referrals can indicate a strong translational culture, yet can also indicate relative isolation from other translational researchers. Notably, ONPRC researchers received no referrals from Knight Cancer Institute researchers despite similar rankings on both funding and number of translational investigators.

In addition to narrative on translational strengths, interviewed investigators mentioned a couple of challenges faced by ONPRC, namely public relations and the maintenance of a strong relationship with the OHSU main campus. This relationship is key to advancing primate work into the next stage of translation. Primate Center researchers who want to conduct a clinical trial, for example, need to partner with someone external to ONPRC.

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FIGURE 7: REFERRALS TO ONPRC

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di s C u s s i o n &li m i TaT i o n s

Over the past couple of decades, translational research has become increasingly important to institutions looking to establish and maintain federal funding streams. In 2006, the launch of the CTSA program gave translational research a funded advocate at participating academic medical centers such as OHSU. CTSAs and their home institutions, however, continue to struggle with establishing a consistent definition of translational research. This makes it difficult to target funds and establish service areas. The STINT study interview results confirm this ambiguity, and call upon translational stakeholders to clarify their role in the translational pipeline.

Audiences familiar with the OHSU research landscape will not be surprised by the majority of the findings in this report. Individual elements of the included strengths and barriers in translational research are well-supported through anecdotal evidence and through other attempts to survey the research landscape. The STINT study is unique in that its focus is on presenting a holistic view of the culture, science, and systems that support translational research as a construct distinct from other research designations. The selected methodology allows these themes to extend beyond anecdotalism.

For STINT interviewees, it appears that translational strengths are rooted in successful science. Large groups of translational researchers at the Knight Cancer Institute and at ONPRC are complemented by less well-known and emerging strengths such as cardiology, vaccine, and hearing research. Culturally, translational researchers are supported by a small and dynamic research institution that facilitates collaboration and collegiality. OHSU has an opportunity to capitalize on these strengths by improving communication between all translational researchers, but particularly between basic scientists and clinician scientists. Other findings regarding local barriers present additional opportunities for OHSU leadership to improve elements of supportive infrastructure and to communicate a clear and consistent vision. Investigators are clearly frustrated with the perceived status of research on the OHSU campus. As part of a health care system that encompasses clinical care, research, and education, leadership has a responsibility to integrate and appropriately value all three elements. Augmenting and publicizing local support can help compensate financially and perceptually for an increasingly discouraging macro research system, one in which funding continues to decline and demands on researchers’ time are ever-increasing.

OCTRI, as a CTSA awardee and local voice for translational research, has an opportunity to contribute to high-level campus conversations about the direction and impact of translational research. These efforts, coupled with improved marketing and communication of OCTRI’s mission and services, can benefit both OCTRI and its constituents.

Limitations of this study include sample bias that favors the opinions of highly-funded, established researchers. The thoughts of this group of researchers may not reflect those of early career or otherwise less established investigators. On a similar note, the limited sample size may have caused minority opinions or the opinions of certain sub-groups to be overlooked. The finding that half of all interviewed researchers self-identify as having limited awareness of research activity outside of their own discipline and/or organization may have impacted the strength of the referral network. This paradigm also likely made it more difficult to identify emerging strengths in translational research. Finally, the selected qualitative approach and analysis methods may be unfamiliar to biomedical researchers, causing misinterpretation of the results.

60


Theme RECOMMENDATIONS FOR OHSUStrengths Consistent Strengths

IdentificationCollaboration

Use the Strengths Framework (Table 4) when identifying research strengths

Capitalize on small size of OHSU; facilitate cancer + non-cancer communication & collaboration

Barriers Internal Funding

Multi-Institutional Projects Communication

Increase availability of internal funding options

Address TTBD, contracting, and regulatory barriers to facilitation of multi-institutional projects

Increase communication between basic and clinical researchers and between the hospital and research elements of OHSU

Translational Research Priorities

Clinical Research Infrastructure

Boundary Spanners Uniqueness Best Practices

Identify needs at all phases

Recruit translational faculty that traverse basic+clinical departments

Invest in resources and opportunities unique to OHSU

Gather data from other institutions when considering change

Theme RECOMMENDATIONS FOR OCTRITranslational Definition

Basic Science Community MissionIdentify Basic Science Departments and projects served by OCTRI

Consider how basic lab science aligns with OCTRI’s goals

Define OCTRI’s role in supporting community, health, and policy research

Select a definition of translation & use it consistently

OCTRI Suggestions

Strategy Marketing Customers Services

Communicate OCTRI strategy & lead translational discussions

Disseminate OCTRI participation data & make personal connections with departments

Identify non-OCTRI customers & proportion of young investigators

Research concierge service

re Co m m e n daT i o nsu m m a ry Ta b l e

61


References

(1) The CTSA program at NIH: Opportunities for advancing clinical and translational research (Consensus Report No. 978-0-309-28474-5). Washington, D.C.: National Academies Press.

(2) RFA-TR-12-006: Institutional clinical and translational science award (U54) Retrieved 9/5/2013, 2013, from http://grants.nih.gov/grants/guide/rfa-files/RFA-TR-12-006.html

(3) OCTRI | Oregon clinical & translational research | OHSU Retrieved 9/5/2013, 2013, from http://www.ohsu.edu/xd/research/centers-institutes/octri/index.cfm

(4) Research roadmap | school of medicine | OHSU Retrieved 9/5/2013, 2013, from http://www.ohsu.edu/xd/education/schools/school-of-medicine/faculty/research-roadmap.cfm?WT_rank=1

(5) DePaulo, P. (2000) Sample size for qualitative research. Quirk’s Marketing Research Media.

(6) Special issue: Social network analysis in program evaluation. (2005). New Directions for Evaluation, 2005(107), 25-25-40.

(7) Cohen, J. (1960). A coefficient of agreement for nominal scales. Educational and Psychological Measurement, 20(1), 37-37-46.

(8) De Vries, H., Elliott, M. N., Kanouse, D. E., & Teleki, S. S. (2008). Using pooled kappa to summarize interrater agreements across many items. Field Methods, 20(3), 272-272-282.

(9) Anderson, C. (2010). Presenting and evaluating qualitative research. American Journal of Pharmaceutical Education, 74(8).

(10) Maxwell, J. A. (2010). Using numbers in qualitative research. Qualitative Inquiry, 16(6), 475-482.

(11) Miles, Matthew B., Huberman,A.M.,. (1994). Qualitative data analysis : An expanded sourcebook. Thousand Oaks: Sage Publications.

(12) Henderson, S., & Segal, E. H. (2013). Visualizing qualitative data in evaluation research. New Directions for Evaluation, 2013(139), 53-71.

(13) Trochim, W., Kane, C., Graham, M. J., & Pincus, H. A. (2011). Evaluating translational research: A process marker model. Clinical and Translational Science, 4(3), 153-162.

(14) Feeney, M. K., Johnson, T., & Welch, E. W. (2013). Methods for identifying translational researchers. Evaluation & the Health Professions (Published online before print September 23, 2013).

(15) Ernst, C., & Yip, J. (2009). Boundary spanning leadership: Tactics to bridge social identity groups in organizations. In T. Pittinsky (Ed.), Crossing the divide: Intergroup leadership in a world of difference. Boston, MA: Harvard Business School Press.

Report Produced by the OCTRI Office of Research [email protected]

Adrienne Zell, PHDManager, OCTRI Office of Research [email protected]

Lindsey Smith, MPPResearch Assistant/Data Whisperer, OCTRI Office of Research [email protected]

David Dilts, PHD, MBAFormer Director, OCTRI Office of Research [email protected]

translational strengths at ohsu translational strengths at ohsu (stint) study was conducted by the...

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