Dive Brief:

• The Food and Drug Administration published draft guidance on Wednesday for diversity action plans intended to increase enrollment of underrepresented groups in clinical trials. 
• A year-and-a-half after Congress passed legislation requiring clinical trial diversity action plans, the agency explained which device trials must meet the requirements and presented a timeline for implementation.
• The draft is open for feedback for 90 days, giving sponsors a chance to comment on the FDA’s interpretation of legal requirements such as the need to share enrollment goals in the plans.

Dive Insight:

Congress passed a law in 2022 that would require drug- and device-makers to submit diversity action plans to the FDA. Per the law, the FDA was required to publish draft guidance clarifying the format and content of the diversity action plans by Dec. 29, 2023.

In the draft, the FDA says that, while the Act “refers to clinical studies broadly,” it does not intend to receive or review plans for “studies that are not designed to collect definitive evidence of the safety and effectiveness of a device for a specified intended use.”  

The restriction of the requirement to studies that serve as the primary basis for the FDA’s evaluation of safety and effectiveness reflects the belief that the plans “may not be particularly meaningful for certain device studies.” The agency named “small studies conducted during the exploratory clinical stage” as an example. Even so, the FDA “strongly recommends” sponsors have a diversity strategy for all trials. 

Other sections of the draft guidance flesh out the requirements of the Act. The legislation requires the plans to include the sponsor's goals for enrollment in the clinical trial, the rationale for the objectives and how they will be achieved. However, the law lacks details of the “form and manner” of the plans.

In the draft, the FDA clarifies that sponsors should disaggregate their goals “by the race, ethnicity, sex and age group of the clinically relevant study population.” The agency wants sponsors to base goals on the estimated prevalence or incidence of the disease.

The legislation states the diversity action plans will apply to clinical trials that start enrollment 180 days after the publication of final guidance on the topic. However, the FDA is proposing to alter the transition because “sponsors engage in study planning and implementing study activities prior to when enrollment commences.”

Sponsors that file applications to run IDE trials within 180 days of the publication of the final guidance will be exempt from the diversity action plan requirement. Similarly, the FDA does not expect sponsors of non-IDE trials to submit diversity plans if their studies are approved by an institutional review board or independent ethics committee within 180 days of the publication of the guidance.