I believe both approaches have been used by sponsors. For drugs, the sponsor can submit it with (or before) the pivotal trial protocol; for devices, it likely makes more sense to put the overall program goals in the action plan.
Given the recently enacted FDORA, one would probably expect to see new guidance documents or updated ones on this topic. In addition to filling in the execution details (e.g. when, how, and criteria for waiver), at a higher level:
- The statute calls for diversity plan for age, gender, and socioeconomic status etc, in addition to race and ethnicity. The agency had a guidance with this broad definition of diversity two years earlier, but it does not ask for formal diversity plans.
- The legal framework seems to be slightly different for drugs and devices (section 505(g) and 520(z)(9), respectively, in the amended FD&C). For example, the action plan is required for registrational studies in an IND, whereas it appears to be required for all trials in an IDE (and trials on devices for which an IDE is not required). The statute says nothing about post marketing studies for drugs, but for those authorized through the accelerated approval pathway, the agency has been requesting a diversity plan for just about every post-approval confirmatory trial.
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Jiwen Chen
United States
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Original Message:
Sent: 20-Feb-2023 22:08
From: Anonymous Member
Subject: FDA Diversity Plan Guidance
This message was posted by a user wishing to remain anonymous
I can see each trial might need its own strategy, but how do you tie them together in the overall plan and results?
Original Message:
Sent: 20-Feb-2023 17:07
From: Meredith Brown-Tuttle
Subject: FDA Diversity Plan Guidance
My interpretation is that it is for the individual trial and am implementing it in that way.
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Meredith Brown-Tuttle, RAC, FRAPS
President
Regulatorium
Santa Clara CA
United States
Original Message:
Sent: 17-Feb-2023 09:43
From: Monique Franc
Subject: FDA Diversity Plan Guidance
RE FDA Guidance on Diversity Plans: https://www.fda.gov/media/157635/download
Dear Community,
My interpretation of the FDA Guidance on Diversity Plans is that FDA expects to see a single diversity plan for the overall development program. I am hearing that some companies are developing individual diversity plans for individual clinical trials. I would appreciate thoughts on and experience with these two approaches.
Thank you,
Monique
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Monique Franc
Scientific Director
North America Regulatory Lead - Neuroscience
Janssen
NJ, USA
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