FDA Includes Telehealth In Draft Guide On Decentralized Trials

FDA on Tuesday (May 2) published draft guidance for clinical trials that occur outside of traditional trial sites, including through telehealth , in a bid to expand diversity and breadth of clinical trial participants. In general, investigators can opt for telehealth visits if an in-person visit isn’t necessary -- the protocol should specify when a telehealth visit would suffice over an in-person visit. The draft guidance lays out considerations for decentralized clinical trial (DCT) designs as well as how...