The FDA announced a new initiative for real-time access to clinical trial safety and efficacy data via cloud platforms, with AstraZeneca and Amgen as initial pilot participants.12
AstraZeneca's Phase 2 TRAVERSE trial tests Calquence with Venclexta and rituximab for treatment-naïve mantle cell lymphoma; FDA has received and validated data via Paradigm Health's platform.124
Amgen's Phase 1b trial involves Imdelltra (DLL3 T-cell engager) or tarlatamab for small cell lung cancer.124
FDA Commissioner Marty Makary stated this approach could transform trials by allowing regulators to view signals like fevers or tumor shrinkage in real time, addressing lengthy drug development timelines.12
A summer pilot for AI-optimized early trials is planned, with public comments sought on design, metrics, and AI applications like safety monitoring and patient recruitment.125
The initiative complements traditional methods and focuses on pre-agreed endpoints, with potential to reduce trial durations by 20-40%.5
Sources:
1. https://www.fiercebiotech.com/biotech/fda-unveils-plan-real-time-review-clinical-trial-data-astrazeneca-and-amgen-already-board
2. https://www.biospace.com/fda/amgen-astrazeneca-join-fda-effort-harnessing-cloud-for-real-time-clinical-trials
4. https://www.statnews.com/2026/04/28/fda-real-time-clinical-trials-pilot-project-astrazeneca-amgen-cancer-drugs/
5. https://www.axios.com/2026/04/29/fda-ai-track-clinical-trials-real-time