Three friends-Jim, Bill and Peter-- were walking down the street. Jim said, "I gave blood today." Peter said, "That's terrific! You are a scholar and a gentleman."

Bill said, "After a lot of thought, I've decided to donate a kidney." Jim said, "That's beyond terrific! You are a prince among men."

Peter said, "Well, I'm not giving blood, and I'm not donating a kidney, but I plan to enroll in a clinical trial tomorrow." Jim and Bill said, "What? Are you crazy?"

PUBLIC PERCEPTION IS POOR

WHY WE NEED TO TELL THIS STORY

RECRUITMENT COSTS ARE INCREASING

Study Recruitment Target

Actual # Recruited

H.Pylori testing eradication vs empirical acid suppressions

730 70Closed at 19

months

Early endoscopy vs. usual management in patients (+) for H.Pylori

800 272Closed at 18

months

H.Pylori testing and eradication with endoscopy of not improved versus early endoscopy

500 500Closed at 14

months

Foy, 2003

Continuing medical education for physician and staff

Printed educational materials for subjects

Incentives to patients

Use of local opinion leaders

Minorities are less likely to enroll in studies compared to white males

Despite high disease burden, less than 5% of participants in Breast and Prostate Cancer prevention trials were minority

1996 to 2002 annual # of trial participants increased from 8,000-12,000 but minority participation decreased. Hispanic & Blacks represented 3.7% and 11.0% in 1996 but down to 3.0% and 7.9% in 2002

Murthy, 2004

• Local Data:Fox Chase Cancer Center (Northeast

Philadelphia)-data from 2004Catchment area: 18% Black, 6% Hispanic,

3% Asian, 71% WhiteMinority patient accrual: 8% Black, 2%

Hispanic, 1% Asian, 89% WhiteMinority patient recruitment: 6% Black,

<1% Asian and Hispanic each

Bruner, 2006

UMDNJ – University Hospital (UH) dataIn 2007 there were 1132 newly identified cancer

patients: 32% white NH, 35% black NH,23% Hispanic.

There were 43 active cancer trials that enrolled a total of 54 patients, representing an overall enrollment rate of 4.8%.

5.1% of blacks enrolled (20/396)4.6% of Latinos enrolled (12/260)

Thus, participation rates among racial and ethnic groups were similar at UH.

Minority Participation: UH Experience

Protocol issues Adequate Funding Site Selection Investigator Selection

Time Constraints Lack of support staff Impact on doctor-patient relationship Concern for patients Clinician bias

Loss of professional autonomy Obtaining consent Poor financial reimbursement Lack of interest in the specific research

question

Demands of the study Preference for a particular treatment Concerns about side effects Comfort level with physician Language and literacy Loss of privacy Portrayal as guinea pig

Mistrust of scientific investigators and of academic institutions were major barriers among Blacks

Providing informed consent was reported as relinquishing rather than protecting rights

Research volunteer is considered a“guinea pig”

Knowledge of the Tuskegee Syphilis Study was not necessarily negatively associated with willingness to participate

Yancey, 2006

Belief Blacks (%) Whites (%)

Risks equally shared by all racial/ethnic groups

34.6 40.5

Minorities bear most of the risk

25.2 5.2

Risks equally shared by rich and poor

22.8 57.8

Poor bear most of the risks

65.9 42.2

Rich bear most of the risks

11.3 0

Shavers, 2002

Systematic review to determine barriers to participation of underrepresented populations in cancer trials: 1966-2005

Barriers to: -trial awareness-opportunity to participate (research design,

provider attitudes)-acceptance of enrollment (perceived harms,

mistrust)--additional barriers related to cultural factors

Ford, 2007

Examination of Community Members’, Researchers’ and Health Professional perceptions of barriers to minority recruitment (Robinson JM, 2007)

Cluster: Recruitment Issues

Minorities unaware of medical research

Lack of cultural sensitivity in communications

Lack of resources to treat the uninsured if found to be sick

Cluster: Patient concerns

Lack of awareness of benefits to participation

Sense that subjects only give and get nothing

Concerns about signing ICF Cluster: Fears

Fear of being a guinea pig

Fear of unknown

Cluster: Psychosocial/socioeconomic issues

More pressing survival problems

Cultural beliefs/Religious beliefs

Mental illness, homelessness Cluster: History/past experiences

Previous negative experience

Literacy issues

Mistrust due to discriminatory social/historical/legal experiences

Cluster: Resources/Financial considerations

Lack of health coverage to reimburse medical interventions in protocol

Presentation at late stage for many minority patients

Dismal past record of translating research into practice in underserved community

Cluster: Research System Issues

Lack of adequate MD education in providing patient’s information about trials

Lack of incentive for overworked MDs caring for minorities Inappropriate outreach methods

Cluster: Researcher Bias

MD fear of losing patients

Poor Relationship between medical institution and community

Lack of follow-up Cluster: Issues in Research Method, Design,

Management

Not linking research to what minority communities need

Lack of minorities as PI

Lack of bilingual researchers

Outreach worker Researcher

Issues with methods Pt. concerns about research

Research system issues Research system issues

Resources/ Financial Recruitment Issues

Recruitment Issues Fears

Pt concerns about research

Issues with methods

MD Bias Resources/Financial

History/past experiences MD Bias

Fears Psychosocial/socioeconomic

Psychosocial/socioeconomic

History/past experiencesR=.29

Lay community Steering Committee

Pt. concerns about research

Research System Issues

Fears Pt. concerns about research

Psychosocial/Socioeconomic

Recruitment Issues

Issues in research methods

Issues in Research Methods

MD Bias Fears

History/ Past Experiences Resources/Financial

Research system Issues History/past experiences

Resources/Financial MD Bias

Recruitment Issues Psychosocial/socioeconomic

R=.11

Lay community Outreach worker

Pt. concerns about research process

Issues with methods

Fears Research system issues

Psychosocial/Socioeconomic

Resources/ Financial

Issues in research methods

Recruitment Issues

MD Bias Pt concerns about research

History/ Past Experiences MD Bias

Research system Issues History/past experiences

Resources/Financial Fears

Recruitment Issues Psychosocial/socioeconomic

R=-.16

NIH Revitalization Act mandated minority inclusion in randomized clinical trials, 1993

Review criteria in NIH study sections have formally required minority recruitment or scientific justification for their exclusion

Rep. Edolphus Towns (Democrat, NY) was expected to submit legislation that would offer delayed generic competition to companies that conduct minority focused clinical trials.

Passive-disseminating information in the target population via flyers, advertisements, mailings, public service announcements

Active-bringing the project staff directly into contact with prospective participants via telephone or in-person appeals by project staff and medical providers

Use lay outreach workers from the targeted population (cultural insider)

Community-based organizations particularly for Blacks

Places of Worship: Although some investigators have identified religiosity as a barrier due to a fatalistic view of disease –others have found religiosity to be positively associated with willingness to participate

Very few patients are aware that they are eligible to participateIn a clinical trial

What is it?

One day educational program free and open to the public

Local physician speakers provide information to help people make informed decisions about clinical research participation General session lecture –

“What Clinical Research Means to You!” Educational workshops –

focused on disease states and issues such as women or minorities in clinical research

Patient Panel – real life stories of clinical research participation

Purpose and Value

Takes awareness-building into the heart of the community via traditional outreach and advocacy strategies

Builds a grass-roots movement by engaging and informing political figures, opinion leaders, physicians, healthcare providers and other stakeholders

Changes perception of the clinical research participant from that of “guinea pig” to that of Hero

Poor (24%)

Fair (29%)

Good (33%)

Excellent (14%)

Poor (1%)

Fair (6%)

Good (51%)

Excellent (42%)

Attendee Evaluations

Self-reported knowledge of the clinical research process: Attendees who were not previously in a clinical trial

Before AWARE for All After AWARE for All

n = 66 n = 65

Less likely (3%)

No Change (22%)

More likely (75%)

Attendee Evaluations

Likelihood of participating in a clinical trial:

n = 108

Recruitment Strategy: Minority Principle Investigators Minority investigators are under-

represented among the pool of all active clinical investigators (Getz, 2008)

# Minorities who are PI

% minority PI

% of all PIs

White % of white MDs involved in research

% of all PIs

All clinical research

14,187 (out of 136,416)

10.4% 16.7% 70,702 (out of 420,846)

16.8% 83.3%

Gov’t funded

6,957 5.1% 19.1% 29,459 7.0% 80.9%

All industry funded research

11,595 8.5% 17.1% 56,393 13.4% 82.9%

Recruitment Strategy: Friendly Informed Consent Health literacy: degree to which people can obtain,

process and understand basic health information and services they need to make appropriate health decisions. It is not just about reading and writing, but includes all the ways people communicate health information such as by speaking, drawing pictures and using technology.

Most consents are on a 12th grade reading level Provide consent in different languages, use

“comfort” words, pictures, diagrams Voice-enhanced ICF Yates, 2009 developed a 23 page ppt flip chart for

an IC-study comparing traditional cardiac rehab vs home-based cardiac rehab-improved participation rate from 22%-54%

Recruitment Strategy: Clinical Trial Alert Systems

Configured the EHR to trigger an alert if a patient is likely eligible for an ongoing clinical trial

CTA is set to trigger only during clinical encounters

If MD elects to proceed , a customized CTA order form appears—reminds MD to assess a few additional eligibility criteria

MD clicks appropriate box 1) yes patient meets criteria and is interested;2. No, patient does not meet criteria; 3. No patient meets criteria but not interested. Message sent to trial coordinator’s workstation

CTA addresses obstacles to MD participation in recruitment

Recruitment Strategy: General Adequately characterize the target population Involve members of the target population in

planning efforts Take message to the target population Give something back to the community Enhance credibility of study by using a community

spokesperson Identify and remove barriers to participation Cultural relevance of materials Improve staff sensitivity Stress importance of prevention and early

detection Use of women to encourage participation by males

Mass mailing of brochures/flyers with personalized letters -across ethnic groups

Secondary source was referral by a friend for Hispanics and Blacks and newspaper ads/articles and brochures for whites

Overall recruitment through the health system produced a higher randomization yield than did newspaper and radio public service announcements or faith-based organizations

Recruits from faith-based organizations were more likely to stay in the study

Study specific websites Email Banner Advertising Chat rooms & forums Podcasts Search engine advertising

Men—newspapers Elderly—TV and newspapers Adult children and spouses of the

patient-direct mail, newspapers, radio and online advertising

Young mothers--magazines and online advertising

Creative Get noticed Offers news Compelling message Succinct message Meaningful to patient Use Emotion Pleasing colors Catchy study name

Conclusions

There is equal willingness among minorities and whites to participate in clinical trials

Lack of awareness and lack of understanding of the benefits of participation are probably the biggest obstacles

Mistrust remains an issue Community involvement is imperative

for enrollment to grow

No more hand-me-downs:Research Designed for Children

Bruner, D.W., et al., Reducing cancer disparities for minorities: a multidisciplinary research agenda to improve patient access to health systems, clinical trials, and effective cancer therapy. Journal of Clinical Oncology, 2008. 24(14): p. 2209-2215.

Ford J.G, et al., Barriers to recruiting underrepresented populations to cancer clinical trials: A systematic review. Cancer, 2008. 112(2): p. 228-242.

Foy, R., et al., How evidence based are recruitment strategies to randomized controlled trials in primary care? Experience from seven studies. Family Practice, 2003. 20(1).

Getz, K. and L. Faden, Racial disparities among clinical research investigators. American Journal of Therapeutics, 2008. 15: p. 3-11.

Joseph, G., C.P. Kaplan, and R.J. Pasick, Recruiting low-income healthy women to research: an exploratory study. Ethnicity and Health, 2007. 12(5): p. 497-519.

Murthy, V.H., H.M. Krumholz, and C.P. Gross, Participation in cancer clinical trials. JAMA, 2004. 291(22): p. 2720-2727.

Robinson, J.M. and M.K. Trochim, An examination of community members', researchers' and health professionals' perceptions of barriers to minority participation in medical research: an application of concept mapping. Ethnicity and Health, 2007. 12(5): p. 521-539.

Shavers, V.L., C.F. Lynch, and L.F. Burmeister, Racial differences in factors that influence the willingness to participate in medical research studies. Annals of Epidemiology, 2002. 12: p. 248-256.

Yancey, A.K., A.N. Ortega, and S.K. Kumanyika, Effective recruitment and retention of minority research participants. Annual Review of Public Health, 2006. 27: p. 1-28.

Yates, B.C., et al., Testing an Alternate Informed Consent Process. Nursing Research 2009. 58(2): p. 135-139.