FDA Issues Draft Guidance on Integrating Clinical Trials into Routine Clinical Practice and Enhancing Diversity in Clinical Studies

Diversity Action Plans (DAPs):
The FDA has released a draft guidance on Diversity Action Plans to improve enrollment of participants from underrepresented populations in clinical studies, as required by the Food and Drug Omnibus Reform Act (FDORA).

Routine Clinical Practice Integration:
The FDA also provides guidance on conducting clinical trials with decentralized elements, including integrating trials into routine clinical practice, which can involve local healthcare providers and facilities.

Decentralized Clinical Trials (DCTs):
DCTs can be appropriate for investigational products with well-characterized safety profiles and may involve a network of locations where trial personnel and local healthcare providers work together.

Enrollment Goals:
Sponsors should set enrollment goals based on the estimated prevalence or incidence of the disease or condition in the U.S. intended use population, considering age, sex, race, and ethnicity.

Implementation Timeline:
The DAP requirements will apply to clinical studies for which enrollment commences 180 days after publication of the final guidance, expected to be effective for trials starting in late 2025.

Waivers:
Full or partial waivers of the DAP submission requirement may be granted in rare instances, with the FDA generally expecting submission of a DAP in most cases.

Transparency:
The FDA encourages sponsors to consider publicly posting key information from their DAPs to promote transparency.

Regulatory Framework:
The draft guidance is part of the FDA's broader efforts to enhance diversity in clinical trials and improve the conduct of clinical research, aligning with FDORA's requirements.