What question did this study set out to answer?

The aim is to establish a real-time reporting system for clinical trial endpoints and data signals.

June 19, 2026Cancer Discovery0 citations

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.

Abstract

The FDA has launched a pilot program to establish real-time clinical trials that includes two proof-of-concept clinical trials that will report endpoints and data signals in real time. AstraZeneca is conducting TrAVeRse, a phase II trial in treatment-naïve mantle cell lymphoma, and Amgen is planning the phase Ib STREAM-SCLC study in limited-stage small cell lung carcinoma.

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