FDA Issues Guidance for Decentralized Clinical Trials
NHIA applauds the guidance issued by FDA to allow for decentralized clinical trials, including in patients’ homes. NHIA believes that allowing decentralized clinical trials will improve the representation in trials. According to the FDA guidance, “remote clinical trial visits and clinical trial-related activities are important strategies to make trials more convenient and more accessible” and “sponsors should strive for diversity and inclusiveness in trial populations.”