Academic Home for The Ohio State University
Clinical and Translational Science Award
Impetus for the CTSA Program
To ensure new discoveries lead to improved public health, clinical science must evolve to better:
Implement biomedical discoveries.
Develop, test, and bring new prevention strategies into medical practice more rapidly.
Catalyze change - lower barriers between disciplines.
Encourage creative and innovative approaches.
Sharing a Common Vision
Working together as a national consortium, CTSA institutions share a common
vision to improve human health by transforming the
research and training environment to enhance the
efficiency and quality of clinical and translational
research.
CollaborationBreaking Down Institutional Barriers
Team Science
Connectivity Partnerships
CTSA Philosophy
• transformative of an academic culture to support the development of a discipline of clinical and translational science
• innovative by supporting new teams and research methodologies to apply to heath research opportunities
• inclusive by engaging faculty, staff and students from the 7 Health Sciences Colleges and the University community who share a common vision about clinical and translational science
• responsive to needs and emerging priorities
• transparent in factors considered in resource and activity allocation
OSU CCTS Values
Basic ScienceDiscovery
Clinical ResearchTranslation
Community Translation Best Practices
Increase research efficiencyFaster adoption of new findings to patient care
T1 T2
The Challenges for Clinical and Translational Research
17 years
Create an academic discipline of clinical and translational science to accelerate the transition of basic discovery to best practices
Overarching Goal
Objectives
Create and support new teams Increase efficiency through integrating research infrastructure Support innovation
Integration of Clinical and Translational Science
Specialized cores
Enhance Efficiency Through Advances in Clinical and Translational Research Infrastructure
Study Design
IRB Submission
Recruitment
CommunityDissemination
Results
Budgeting
Study Implementation
CommunityInput
Basic ScienceDiscovery
Input
Design and Team
Development
RegulatoryProject Management
Recruitment
Clinical Research Center, PBRN, Community Partners
Scientific coresData management
BiomedicalInformatics
BiostatisticalAnalysis
Grants and Contracts
IP and Tech Licensing
What Does the CCTS Have Available To Support My Career?• Everyone
– Education, training and career development• Seminars • Special focus groups• TL1 (pre and post-doctoral) and
KL2 (clinician scientist) trainee support• MPH in clinical and translational science• Formal mentoring programs (and mentor
training)*• Graduate interdisciplinary specialization in
biomedical, clinical and translational science (IBGP)*
– Research networking tools*– Informatics tool kits
• T1 investigators– MS and PhD in Translational Science– Biostatistics study design for grant
submission– Integration with clinical research teams– New drug discovery and comparative
animal cores– Pilot funding initiatives
• Linking basic science with clinical research• Methodologic research
– Support creation of biorepository and further development of tools for deep phenotyping within IW*
• Clinical Research Investigators– Biostatistics and ethics study design– Regulatory expertise and assistance– Recruitment Office– Access to research nurses and study
implementation through CRC or PBRN– Specialized cores for laboratory processing,
nutrition analyses and body (musculoskeletal) composition
– Pilot funding initiatives – Development of imaging core next year*– Development of training opportunities for
research staff*• T2 investigators
– PhD in Implementation Science*– Toolkit supporting community-based
participatory research• Community partners and sites
– Community engagement pilot funding
* Under development
CCTS Programs and Cores
Biostatistics and Research Design
• Support for design, analysis and proposal preparationo Clinical trial designo Laboratory experimental designo Microarray data analysiso Modeling of complex data
• Consultation for ethical and regulatory issues
• Develop and implement new statistical methods specifically for C/T research
• Free biostatistics walk-in clinic Thursdays, 11:00-1:00 pmCCTS, Suite 205 Prior Health Sciences Library
Biomedical Informatics
• Perform consultation on:– Informatics requirements analysis and project planning– Database design, optimization and development
• Facilitate access to data stored in the OSUMC Information Warehouse• Provide access to and support of tools enabling:
– Research data collection and management, including REDCap and StudyTrax– Creation and management of web-based surveys, including REDCap Survey– Research networking, including Microsoft Office Sharepoint Server (MOSS)
• Facilitate data integration via– Development and management of grid computing infrastructure (TRIAD)– Provision of comprehensive knowledge engineering services
• Provide training and education programs for supported tools, data modeling, grid services creation and biomedical informatics
Translational Technologies and Core Resources• Drug discovery
o Chemical and radiochemical support services for drug discoveryo Pharmacoanalytic instrumentation for support of PK/PD studies in
Phase I-III clinical drug development
• Laser capture microdissection (LCM) molecular coreo Sample preparation for LCM including staining, LCM, proteomics,
genomics, microRNA analysis on micro-samples (picogram-nanogram quantities)
• Biomedical Imaging Resource• Comparative Animal Core
o Animal tissue biorepositoryo Mouse phenotyping and pathologyo Veterinary clinical trials office
CE squared: CE (Community Engagement) and CER (Comparative Effectiveness Research)
• Pilot funds for CER research studies
• Assistance in design, methods and community assessment/partnership
• Training opportunities including a national conference which brings together investigators and stakeholders
• Comparative Effectiveness Research training supplement grant pending
Pilot and Collaborative Studies
• Requests for applications (RFAs) to support new or early stage investigators or new teams of established researcherso To date, 48 pilot grants funded
• Leverage CCTS pilot funds with collaboration from other programs and centers to create additional research opportunities– Partner with Fisher College of Business for series of 5
workshops “Discovery, Innovation and Commercialization”
• Assist with research team building
Tracking and Evaluation
• Outcomes assessment including non-clinical and social• Health economics analysis• Healthcare policy analysis• Social network analysis• Survey research• Lean and Six Sigma approaches to process and quality
improvement• Implementation science research
Regulatory Knowledge and Ethics
• Provide support to research teams to fulfill human subject research regulatory requirements without the loss of their sense of responsibility
• Establish educational modules as well as standardized, tiered training curricula for researchers and coordinate current educational efforts
• Assist with development of and participation in data safety monitoring activities
• Research Subject Advocate for IRB and/or PI requested protocols
Clinical Research Center
• OSU research unit providing both inpatient and outpatient services including nursing staff and bionutrition facilities and expertise
• Exercise physiology and body composition laboratories
• Specimen processing and core laboratory• Specialist in recruitment and retention of research
participants including ResearchMatch.org• Clinical trial protocol and budget development
Nationwide Children’s HospitalClinical Research Services
• 4000 sq ft Clinical Research Center at NCH• Research Nurses, Coordinators and IRB Support• Overall study management provided by extensively trained
research coordinators• Research project consultation and study design assistance,
clinical research budget development• Data Collection for subject tracking to ensure proper
invoicing and revenue capture• Clinical Research Training
• Psychometric evaluation• Investigators have access to all of the services provided
by NCH
Research Education, Trainingand Career Development
• Developing a dynamic curriculum in clinical and translational science (example: PH795)
• Provides research education resources and training including workshops, podcasts, online resources, seminars
• Mentoring workshops*
*Under development
How do I access the CCTS programs and resources?
• Visit the CCTS website (www.ccts.osu.edu) and become a CCTS member
• Log in and fill out a Request for Resources
• Or, contact the Research Concierge
www.ccts.osu.edu
Research Concierge
• Facilitate access to CCTS programs and cores
• Locate OSU/NCH resources, cores and expertise
• Assemble new research teams
• Assist with navigation of OSU research infrastructure
• Vendor information for equipment, instruments, supplies, etc.
• Information on funding opportunities including pilot grants
Leveraging the unique talents and expertise across
OSU, the CCTS is fitting together the pieces of a puzzle of basic science discovery and clinical
research to improve health outcomes for each individual
in the community