FDA Partners with Amgen and AstraZeneca for Real-Time Clinical Trials Using Cloud Technology
The FDA has launched an initiative to streamline drug development and review processes through real-time clinical trials, utilizing cloud technology. Amgen and AstraZeneca are participating in this pilot program, which allows FDA reviewers to access safety signals and clinical endpoints in real-time during trials. AstraZeneca will apply this system in its Phase 2 TRAVERSE study for mantle cell lymphoma, while Amgen will use it for the Phase 1b STREAM-SCLC study in small cell lung cancer. The FDA has successfully validated data from AstraZeneca's program, demonstrating the feasibility of real-time data sharing. The agency is also seeking public feedback on the framework's design and implementation. 
