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. 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

3. 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!

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 ,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
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

8. 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://
2FDA, Drug Trials Snapshots Summary Report.

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

10. 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 …

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

12. 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 February ; 101(2): 179–183.

13. 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.

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

15. 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.

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

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

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