FDA Launches AI-Powered Real-Time Clinical Trial Initiative with AstraZeneca and Amgen
The FDA has announced a new initiative to utilize artificial intelligence (AI) in clinical trials, aiming to accelerate drug development by allowing real-time data reporting. AstraZeneca and Amgen are set to pilot this model, with two trials planned to report endpoints and data signals to the FDA as they occur. This approach seeks to address the traditional bottlenecks in drug development, characterized by high uncertainty and inefficient decision-making processes. FDA Commissioner Marty Makary, alongside the agency's first chief AI officer, Jeremy Walsh, emphasized the potential of this modern approach to transform clinical trials by enabling continuous data monitoring. The initiative includes a request for information (RFI) to gather feedback on the proposal, with comments open until May 29. The pilot studies involve AstraZeneca's phase 2 TrAVeRse trial and Amgen's phase 1b STREAM-SCLC trial, focusing on innovative cancer treatments. 
