AI Article Synopsis
- The FDA requires marketing authorization for products to include clinical data that reflects the US patient population, emphasizing the need for ethnically diverse foreign clinical data conducted under Good Clinical Practices.
- The recent Omnibus Legislation gives the FDA the power to mandate Diversity Plans for Phase 3 clinical trials, aiming to improve participation from underrepresented racial and ethnic groups.
- A guidance document issued by the FDA outlines expectations for sponsors on foreign clinical data and enrollment strategies for diverse populations in clinical trials, with an update anticipated in 2023.
Article Abstract
The Food and Drug Administration (FDA) has an expectation that products filed for marketing authorization have to include data that are representative of the US patient population. Any foreign clinical data that is submitted has to represent an ethnically diverse population that is generated utilizing qualified Principal Investigators (PIs) and conducted according to Good Clinical Practices (GCP) requirements outlined in 21 CFR 312.120, Foreign clinical studies not conducted under an IND. With the recent passing of the Omnibus Legislation, FDA now also has the authority to require Diversity Plans for all Phase 3 clinical trials of new drugs or "as appropriate, another pivotal study of a new drug." The FDA has released a guidance document, "Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials" (April 2022), for the industry with expectations to update the document in 2023 now that legislation is passed. This whitepaper discusses the FDA guidance and expectations of sponsors with regards to foreign clinical data and the intersection with enrolling ethnically diverse populations in clinical studies.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11417185 | PMC |
| http://dx.doi.org/10.1016/j.conctc.2024.101331 | DOI Listing |
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