FDA Announces Efforts to Implement Real-Time Clinical Trial Reporting

Key Points

• The aim is to establish a real-time reporting system for clinical trial endpoints and data signals.
• Pilot program launched by FDA for real-time clinical trial reporting.
• Includes two proof-of-concept trials: AstraZeneca's phase II TrAVeRse and Amgen's phase Ib STREAM-SCLC.
• Focus on treatment-naïve mantle cell lymphoma and limited-stage small cell lung carcinoma.
• AstraZeneca's TrAVeRse trial will report endpoints in real time for mantle cell lymphoma.
• Amgen plans to conduct the STREAM-SCLC trial to report data signals as they arise.