The FDA has released guidance on diversity in clinical trials – you can read it here. This was first legislated through the DEPICT act, but the latest guidance provides additional details on how the FDA will enforce the legislation.

The guidance states that a Diversity Action Plan is required for each phase III and pivotal clinical study of a drug. Clinical trial populations must match the Diversity Action Plan, and if diversity requirements are not met, study sponsors will be required to hold additional studies.

This webinar will address ways that life sciences companies can increase representativeness of clinical trials, to meet the new requirements and enrich their study feasibility.