Top 5 Insights from FDA Public Workshop to Enhance Clinical Trial Diversity

The two-day workshop¹ fulfills the requirement under Section 3603 of the Food and Drug Omnibus Reform Act of 2022 (FDORA)

1. Expanded definition of diversity

   The FDA emphasizes a broader definition of diversity beyond race, ethnicity, and gender, including groups like pregnant and lactating persons, children and the elderly, and individuals with intellectual, developmental, or mental health conditions, indicating a shift towards inclusivity in clinical trials.

2. Early planning is crucial: from protocol design to patient engagement

   Panelists highlighted the importance of broadening eligibility criteria during trial design and engaging with communities early in the clinical trial process, even as early as Phase I, which will be crucial to avoid delays in recruiting underrepresented patient populations.

3. Data challenges and use of RWD

   Data collection, integrity, and standardization are significant challenges, especially with varying global standards and legal limitations on collecting sensitive data such as race and ethnicity. Further challenges in collecting data on non-traditional attributes such as gender identity, lactation status, and disability were hot topics on day 1.

   Sponsors should carefully assess the adequacy of the use of RWD, ensuring the RWD source is fit for purpose.

4. Expectation vs. reality: early findings

   Analysis of diversity plans (Project Equity²) revealed that although 87% of plans submitted during the initial one-year period contained all five recommended components, only a small proportion of plans on which the agency provided feedback were deemed acceptable (6%).

5. It takes a village and new roles to enhance diversity in clinical trials

   The FDA acknowledges that a combined effort from all parties involved in clinical trials is essential to ensure success.

   “FDA is only one piece of the puzzle. It takes the combined effort of all interested parties in the clinical trials enterprise,”  Patricia Cavazzoni, Director, FDA Center of Drug Evaluation and Research, highlighted in her opening remarks.

   Boehringer Ingelheim is creating cross-functional new roles titled Clinical Trial Diversity Lead and Team of Diversity Strategists to support its diversity plans.

What are sponsors and CROs expecting?

The FDA focused less on legal and regulatory comments at the recent workshop. However, FDORA mandates the FDA to update existing guidance or issue new guidance according to the requirements in FDORA no later than 12 months from when FDORA was signed into law³ on Dec. 29, 2022.

Sponsors and CROs anxiously await the new/updated guidance to be published soon.

Did you attend the FDA workshop?

Comments are due until Jan. 30, 2024, you can submit your comments here

Want to learn more? With the Sitetrove Diversity Module robust site and investigator intelligence from Sitetrove and rich, real-world US demographic data support diverse patient recruitment.

References:

¹ FDA Final Agenda Public Workshop Nov. 29–30, 2023

² Project Equity – Diversity Plans – Oncology – Year 1 Experience

³ Public Law No. 117-328, Chapter 1, Clinical Trial Diversity and Modernization