Key Takeaways From Clinical Trial Diversity Discussion

By Dan Schell, Chief Editor, Clinical Leader

In our recent Clinical Leader Live, “The Diversity Mandate: Effective Strategies in Clinical Trials” we discussed … well, a lot. For instance, we talked about the need for companies to be deliberate and consistent in their outreach and involvement in communities, not just show up when they want participants for a trial. Focus on partnering with trusted intermediaries and community organizations like Black Health Matters to build relationships and networks in diverse communities to improve clinical trial recruitment. But when approaching these communities, sponsors should start by acknowledging the industry's past mistakes and reputation issues, and then explain why the clinical trial will be beneficial, in order to break down barriers and build trust.

We acknowledged that the data infrastructure and categorization around race, ethnicity, and identity is flawed and needs to evolve to capture more nuanced and accurate information. Sponsors should focus on optimizing protocols and site selection to improve diversity, rather than just relying on historical data which may be incomplete or skewed. Furthermore, simply looking at census data for site selection does not mean those diverse populations are being asked to — or want to — participate in clinical trials.

Of course, we discussed the diversity Guidance and diversity action plans (DAPs) and why there needs to be more accountability and consequences around diversity goals, rather than just guidelines that can be easily waived.

We also touched on topics such as the need to continue educating current and future PIs on not only clinical research, but what “race” means in different cultures. “[Other countries] don't identify it the same way that we identify in the U.S.,” says Stacey Bledsoe, head of global clinical trial diversity and inclusion at Gilead. She adds that, as such, it is important that we respect all cultures and understand how race looks in some of these societies outside the U.S., and that the bigger issue, to them, is often health equity.

25 Questions About Clinical Trial Diversity and DAPs

Throughout the Clinical Leader Live, the 300+ audience was able to submit questions and comments for the panel, which also included Garo Kiledjian, CEO/Founder of SGM Alliance; and Denise Bronner, Ph.D., Founder of Empactful Ventures. Of the nearly 90 comments, I chose the following 25 questions that I felt best represented most of what audience members were asking about. The breadth of these questions clearly indicates that people are still struggling with creating more diverse trials and have many questions about the recent Guidance.

1. What is the future of tech advances that could have an impact on diversity enrollment?
2. What types of diversity strategies do you think are helpful for sponsors of trials in rare disease? How would these be different from considerations for larger patient populations?
3. Many diagnoses have significantly higher prevalence in specific racial and ethnic populations. Can you talk about how to address this in a DAP, especially when the population is white people?
4. How can AI help with improving diversity in trials?
5. What do you think about payers making the achievement of diversity goals an element for consideration when deciding to cover a certain drug or medical intervention?
6. How will the OMB SPD 15 document being updated to include a new racial group such as North African affect how demographics data will be visualized in clinical trial data?
7. What data standards are being leveraged? What is the outlook of leveraging HL7 FHIR data to creating a diversity dashboard?
8. With the guidance indicating the expectation that DAPs will need to made public (on clinicaltrials.gov, study websites, or pipeline web pages), do you think that will continue, or do you think it might change so that only a section of a DAP will be made public?
9. What are your thoughts about areas of intersectionality with race and ethnicity (e.g., gender identity, disability, rural/non-rural locations) that were called out in the guidance, but not stressed?
10. How can we implement a DAP in device studies? And how does the guidance effect IDE studies?
11. What have you seen to be most effective in educational programs (i.e. events in person? webinars?)
12. Where do you see a down syndrome individual fitting into the diversity effort?
13. What are some insights on groups that are apprehensive to western medicine?
14. How do we define and measure success for diversity in trials? What metrics are we using to quantify the proportion of different identities/demographics that are enrolled? How do we account for the sensitivity for certain identities and is participants not disclosing identities even an issue?
15. Can you advise on how much of a certain ethnicity has to be enrolled in a clinical trial?
16. How do you think clinical trial decentralization will impact diversity?
17. How do you educate communities about clinical trials in general vs. talking about a clinical trial?
18. What are you actually doing to partner with patients and communities for engagement where your sites are located? How long do you start in advance of enrollment?
19. Are companies pulling back on diversity initiatives and waiting for the election results?
20. How well are we utilizing CBPR (Community-Based Participatory Research Program) to enhance trust and engagement, cultural relevance and tailoring, and improving recruitment and retention?
21. Is being consistent in the community really a role for pharma? Is that more of a local organizational/governmental responsibility?
22. There are some diseases that are prevalent to certain populations. How do you apply this diversity across all clinical trials?
23. Stacey and Denise have both mentioned community organizations, please provide names.
24. How do SDoH (social determinants of health) and especially behavioral data factor into patient recruitment and retention strategies? i.e., How do factors other than race, gender, or sexual orientation factor into these strategies?
25. Clinical protocols are often template driven (box checking). What efforts need to be taken to get diversity and inclusion “requirements” into things such as the NCCN (National Comprehensive Cancer Network) Guidelines for Oncology protocols?

Clinical Trials Diversity Action Plan (DAP) Resources

• Regulatory Guidance: FDA Diversity Action Plans Guidance
• Conference: Health Equity In Clinical Trials Congress
• Article: Diversity Action Plan (DAP): Creating An Ecosystem For Success
• Video: DiversiTrials and Tribulations: FDA Guidance Community Forum Sections 1 and 2
• Case Study: Diverse Patient Recruitment Begins with Authentic Connection: Reaching Underserved Lupus Patients
• DAP Template: Model Diversity Action Plan