Regulatory Science Symposium: Diversity in Clinical Trials in the Time of COVID-19 Session 2: What Do We Mean by Diversity in Clinical Trials?

1. Learning Objectives
a. Identify dimensions of diversity
b. Describe why diversity in clinical trials (CTs) is important
c. Explain the current landscape of diversity in CTs
d. Describe diversity in CTs of recently approved drugs
2. What is diversity?
3. Dimensions of Diversity
a. Often believed as race, ethnicity, sex, and gender at the surface level
b. Other dimensions can include ancestry
4. Intrinsic vs. Extrinsic Factors
a. Intrinsic factors include genetic and physiological and pathological conditions
b. Extrinsic factors include environmental and culture; they are not innate
5. New products should be appropriate for patients who use them
a. Studies might need to consider genetics, physiological differences, co-morbidities, geography, and multi-factorial
6. Study populations in clinical research
a. Study population should reflect targeted users of the products
7. Bringing a new drug to the market is challenging
8. The process is highly regulated
9. The goal: approved labeling
a. Ideally: Incorporate research from non-clinical to CTs to result in prescribing information; that is adequate for all populations
b. Warnings and dosing information would be tailored to each population
10. Examples where differences exist
a. ACE inhibitors: higher risk of angioedema in Black than non-Black populations
b. Tegretol: higher risk in Asian populations
11. Race and ethnic differences across drugs
12. Need data to provide scientific evidence
13. Demographics in U.S.
14. Demographics in clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA from 2010 to 2012
a. Representation of White individuals is higher here than in the previous slide
15. Lack of diversity (%)
a. Whites are overrepresented in clinical trials
b. Asians are adequately represented
c. Blacks and Hispanics are underrepresented
16. Need clinical trial data to include underrepresented populations
17. Diversity and inclusion in clinical research
a. Refers to identifying subpopulation variability in diagnosis, treatment, and prevention
18. This is complex…
a. Some dimensions of diversity i.e. age and sex represent biological differences
b. Others i.e. race and ethnicity represent social constructs
c. There is an interrelationship between these dimensions of diversity
d. Trust in this clinical trial process is important, as illustrated in the search for a COVID-19 vaccine
19. COVID-19 exposes differences in vulnerability
a. Possible relationships between blood types and susceptibility to COVID-19
20. Nationwide, Black people are dying at 2.3 times the rate of White people
21. Inclusion efforts can be successful
a. Bringing attention to the diversity issue actually makes a difference 
b. Vulnerable populations were being excluded from clinical trials for COVID-19 vaccine
c. In September 2020, Moderna (pharmaceutical company) made efforts to recruit these populations, which increased the representation of these underrepresented groups
22. Questions
a. Some of these questions will be addressed by later speakers
b. Educational Level and Participation in Clinical Trials
c. Level of surprise that Hispanics have not been easier to recruit than Asians
d. Raising the level of awareness and reaching out where patients live and at their language levels
e. Unless there is a genetic component, race is primarily patient-reported
f. Will mixed race increase in the foreseeable future?
g. The issue of trust will be discussed right before lunch, particularly with the Black community and the Tuskegee experiments

Accompanying text created by Annie Ly | Graduate Student, Regulatory Science, USC School of Pharmacy lyannie@usc.edu