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.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-generating-clinical-evidence-oncology-multiregional-clinical-development-programs?utm_medium=email&utm_source=govdelivery Submit comments by November 18, 2024 The FDA issued a draft guidance for industry that, when finalized, will provide sponsors with recommendations for conducting multiregional clinical trials (MRCT) in support of applications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.