Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Draft Guidance for Industry September 2024

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/integrating-randomized-controlled-trials-drug-and-biological-products-routine-clinical-practice?utm_medium=email&utm_source=govdelivery Submit comments by December 17, 2024 The FDA issued this draft guidance to provide recommendations about how clinical trials can be moved into clinical practice settings.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.