So, has the FDA finally decided to use its power to ensure diversity in clinical trials? I say a resounding “YES!!!!”. FINALLY. The guidance issued April 14, 2022 has the teeth needed to push the industry to finally DO something.

This guidance draws heavily from the last guidance issued October 2016. In that guidance the regulatory body suggested a the sponsor have a plan for diversity, if needed, by the end of the Phase II meeting. In this guidance there is a requirement for the plan before even filing for the IND. YEA!!!

The document offers up the reasoning for this change:

The purpose of this guidance is to provide recommendations to sponsors developing medical products2 on the approach for developing a Race and Ethnicity Diversity Plan (henceforth referred to as the “Plan”) to enroll representative numbers of participants from underrepresented racial and ethnic populations in the United States, such as Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of color, in clinical trials. Individuals from these populations are frequently underrepresented in biomedical research despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population.

Adequate representation of these populations in clinical trials and studies supporting regulatory submissions helps ensure that the data generated in the development program reflect the racial and ethnic diversity of the population expected to use the medical product if approved and may potentially identify effects on safety or efficacy outcomes that may be associated with, or occur more frequently within these populations.

Later in the relatively short, 12 page document, the FDA lays out a historical perspective on the need for this guidance:

Some individuals from these groups have often been underrepresented in medical product development and FDA considers their representation in clinical trials and studies to be a priority. FDA has, for some of these populations, already published specific guidance (e.g., enrollment of women, including pregnant and lactating women, and older adults).14,15 However, FDA is focusing this guidance on diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations because the lack of representation of these populations in clinical research reflects, in part, a broader issue regarding differential access to health care16, including access to centers that conduct clinical research programs for new therapies and awareness of clinical trials conducted there. In addition, mistrust of the clinical research system may stem from historical events that adversely impacted racial and ethnic minorities, such as the unethical Tuskegee experiments.

Since the October 2016 guidance was issued the challenge to sponsors had been what to include in the the plan, what was adequate. In this new document the FDA lays out what to include in the plan, how to assess the needs for the plan, how to identify the appropriate populations. As significant as all this is, I have to say, having been brought up in this industry on the commercial side of the business, this is not hard to do. On the commercial side this is simply an understanding of the epidemiology of the therapeutic area. As much as the FDA is leading industry by the hand on this plan I would add that R&D should be meeting with their commercial colleagues to simply get an understanding of the potential market. This is NOT hard to do!

Here are the FDA’s recommended Race and Ethnicity Diversity Plan elements:

FDA Race and Ethnicity Diversity Plan

View a larger version of the Plan here


Here is a link to the April 14, 2022 guidance

Life sciences industry – the FDA has been trying to encourage you to be more inclusive in clinical trials for decades. Finally, here is your roadmap to get it done. There are SO many of us who have been working in this space and can help you get this done. The elements of the plan are no strangers to us. The next posting will outline the resources that can help you get this done. No more excuses!

Just my thoughts,

Dyan Bryson

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