African American Enrollment in Clinical Trials: Barriers and Solutions

1. African American Enrollment in Clinical Trials: Barriers and Solutions Andrea L. Phillips MD Chair, MS Medical and Surgical Assn. Principal Investigator/Director Phillips Medical Services, PLLC Jackson, MS November 16, 2017 HealthyChurches 2020

2. What is a clinical trial? Objectives • Why should we be concerned about clinical trial diversity? • Where do we stand on diversity in clinical trials? • What are some barriers to African American enrollment? • Discuss solution to these barriers

3. A clinical trial is … The key to precision medicine!

4. Why should we be concerned about diversity in clinical trials? 4

5. Documented need for increased diversity in clinical trials Changing face of the population: Minorities are expected to represent over half (52%) of the US population by 2050.1,2 • 1U.S. Census Bureau, 2009 National Projections supplement to the 2008 National Projections, August 14, 2008. 2Clinical Trial Engagement Network. National Minority Quality Forum, 2014.

6. Where do we stand today on clinical trial diversity? 6

7. Few clinical trials with strong minority representation Few CV trials exist with adequate minority representation African American Heart Failure Trial (A-HeFT) for BiDil

8. Where do we stand today on clinical trial diversity? 20162 20152 Information about the sex, age, race and ethnicity of clinical participants for recently approved drugs 1https://www.acrpnet.org/2017/02/14/fda-report-shows-growth-clinical-trial-participation-among-women-african-americans/ 2FDA, 2015-2016 Drug Trials Snapshots Summary Report. https://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM541327.pdf

9. What are some barriers to African American enrollment in clinical trials? 9

10. Barriers are multiple … and multifocal …

11. Barriers to African American Enrollment in Trials • lack of concrete knowledge about clinical research and how it has benefited African Americans in the past • the lack of African Americans in visible leadership roles in clinical studies • distrust of research sites based upon their historical relationship with local African American communities • lack of endorsement of research by trusted grass roots leaders in the community • lack of time and energy to participate in research studies owing to demanding family or job

12. Exploring the “Legacy” of the Tuskegee Syphilis Study: A Followup Study From the Tuskegee Legacy ProjectRalph V. Katz, DMD, et al, J NMA, 2009 Feb • CONCLUSION ‘As these findings validate our prior findings, we conclude that our surveys in 7 US cities, conducted about 3 decades after the termination of the TSS, provide no support for the widely held belief in the “legacy” of the TSS, … that African Americans are more reluctant to participate in biomedical studies than whites due to awareness of the TSS.’

13. Conclusion (cont): We base this conclusion on research that reviewed the decision-making process of 70,000 research volunteers and showed that minority volunteers are just as likely as majority volunteers to participate in clinical trials… When approached by their own physicians.

14. What are theSOLUTIONS ? • They are Multiple… • And Mutifocal …

15. Solutions • Facilitate collaboration between the group of diversecommunity based physicians who serve underrepresented populations and the physician-scientists who have traditionally performed clinical trials on behalf of academic and pharmaceutical entities.

16. Reach into the community Leverage the power of community to effectively recruit minority patients. ABC can help! Community Based Organizations and Advocates Academic Research Centers Local Networks with Access to Diverse Populations Investigator Sites Study Coordinators/ Nurses Patients

17. Solutions • If asked by their own physicians, minority patients are more likely to participate in clinical trials. • Minority physicians who have access to minority patients can be an important source of volunteers for clinical trials. • Minority investigators are very poorly represented in clinical trials in the US today.

18. Solutions • All agencies that fund clinical research should work to build a network of diverse, community-based investigators who can participate in clinical trials. >> NIH, foundations, pharmaceutical and medical device companies, academic medical centers, etc

19. What Can I Do ?

20. YOU can… • Check out new clinical trials on clinicaltrials.gov • Ask your physician or other clinician about clinical trials for your medical problems • Host a health fair and invite Clinical Investigators and Coordinators from your area to screen patients • Invite Investigators to speak to your small group, Sunday school class, civic group, book club, etc • Support a friend or family member who’s interested in participating in a clinical trial

21. Summary • The need for clinical trial diversity is great • Opportunities for participation and professional involvement are widespread • The potential benefits for both individuals and for our community as a whole are tremendous • The time is NOW!

22. Questions