MedCity News May 11, 2023
With the FDA’s acceptance and encouragement of decentralized trials, we can expect to see a continued shift towards remote trial conduct, virtual sites, and the use of innovative digital technologies.
The FDA’s new draft guidance on Decentralized Clinical Trials (DCTs) is a landmark moment for the industry, emphasizing the importance of virtual trials for improving patient access to groundbreaking research while providing recommendations on how to incorporate remote trial elements safely. In this new guidance, the FDA encourages the use of remote clinical trial visits and clinical trial-related activities as important strategies to make trials more convenient and more accessible to participants. The FDA also underscores the need for sponsors to work with experienced vendors that can help navigate the...