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

Objectives What is a clinical trial? 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

The key to precision medicine! A clinical trial is … A carefully designed, controlled, and regulated research study that tests new treatments for medical conditions Closely supervised by qualified physicians and other research professionals The process by which all medications obtain FDA approval for any indication An entirely voluntary process The key to precision medicine!

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

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.

Where do we stand today on clinical trial diversity? 6

Few clinical trials with strong minority representation Few CV trials exist with adequate minority representation The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) The 2015 Systolic Blood Pressure Intervention Trial  (SPRINT)  PLATINUM Diversity: Outcomes with the Promus PREMIER™ Stent in Women and Minorities African American Heart Failure Trial (A-HeFT) for BiDil

Where do we stand today on clinical trial diversity? 20162 Demographic subgroups African American/ Black Asian White Other Participant Average 7% 11% 76% 20152 Information about the sex, age, race and ethnicity of clinical participants for recently approved drugs Demographic subgroups African American/ Black Asian White Other Participant Average 5% 12% 79% 6% 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

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

Barriers are multiple … Five critical barriers identified Lack of information about clinical trial process Lack of awareness of existing clinical trials Lack of comfort with the process Mistrust Time and resource constraints and multifocal …

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 J Natl Med Assoc. 2009 February ; 101(2): 179–183.

Exploring the “Legacy” of the Tuskegee Syphilis Study: A Followup Study From the Tuskegee Legacy Project Ralph 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.’ J Natl Med Assoc. 2009 February ; 101(2): 179–183.

Conclusion (cont): When approached by their own physicians. 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. Maria Alexander-Bridges, M.D. Ph.D., and Loretta L. Doan, Ph.D.

What are the SOLUTIONS ? They are Multiple… And Mutifocal …

Solutions Facilitate collaboration between the group of diverse community based physicians who serve underrepresented populations and the physician-scientists who have traditionally performed clinical trials on behalf of academic and pharmaceutical entities. Maria Alexander-Bridges, M.D. Ph.D., and Loretta L. Doan, Ph.D.

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

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. Alfonso J. Alanis, M.D.† and Ken Getz, M.S., M.B.A.‡

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 Maria Alexander-Bridges, M.D. Ph.D., and Loretta L. Doan, Ph.D.

What Can I Do ?

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

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!

Questions