New FDA Draft Trial Guide Incorporates Decentralized Studies, Wearables, AI

FDA has released a new draft guidance for good clinical practice (GCP) when conducting clinical trials, which aims to harmonize the work of an international regulatory group with the agency’s recent work on incorporating new approaches such as decentralized clinical trials, use of wearable devices and artificial intelligence. The draft guidance , FDA wrote, is intended to apply to a broad range of clinical trials including those that introduce elements to make trials more efficient. The guidance encourages the use...