 FDA Issues Guidances Supporting Clinical Trial Innovation
This week the U.S. Food and Drug Administration issued two draft guidances and one final guidance to support innovative clinical trial approaches, including trials that use decentralized elements, trials that allow integration of research into routine clinical practice and multiregional oncology clinical trials. These approaches can increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges.
Submit comments by December 17, 2024
The FDA issued this draft guidance to provide recommendations about how clinical trials can be moved into clinical practice settings. Also known as "point of care trials," these trials, like decentralized clinical trials, aim to bring trial-related activities to more convenient locations for patients. They may improve convenience and accessibility for participants and allow for enrollment of more representative populations, resulting in more generalizable trial results.
This final guidance provides recommendations for sponsors, investigators, and other interested community members regarding the implementation of clinical trials with decentralized elements. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants.
Submit comments by November 18, 2024
The FDA issued a draft guidance for industry that, when finalized, will provide sponsors with recommendations for conducting multiregional clinical trials (MRCT) in support of applications for drugs intended to treat cancer. An MRCT is a trial that is conducted in more than one region under a single protocol, with region defined as a geographical region, country, or regulatory region.
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