Diversity Action Plans - What do they mean for my clinical program?

In June of this year, the FDA released it’s draft guidance on Diversity Action Plans (DAPs). This draft guidance intends to address what exactly a DAP is and when it is required.

The need for a DAP comes from new provisions of the Federal Food, Drug and Cosmetic Act added by the Food and Drug Omnibus Reform Act (FDORA) and intends to address the often underrepresented populations in clinical studies. The hope is that by openly developing a plan to ensure representation of these populations, enrollment will follow. Not only will the data from a well executed DAP allow for better data in understanding the safety and efficacy of an entire treatment population, it will also provide better clinical data to enform therapy development.

The guidance outlines when a DAP will be required. In short, it is required for any study that will be used for submission to the FDA for market approval. For medical devices, this means that it would not be required for early phase exploratory studies such as First-in-Man or Feasibility studies but it would be required for the pivotal study or any study whose data will be part of a submission for approval. Having said that, just like all aspects of a clinical program, companies should be thinking now about how the requirements of this guidance document will be met.

This guidance will apply to all studies enrolling within 180-days of the issuance of the final guidance. So there is time to think about this but the time is now rather than finding yourself behind when you are trying to get your IDE approved for your pivotal study.

Reach out to me to discuss further and what tools, such as decentralized trials - which I will write about soon - may help meet the requirement of a DAP.