The U.S. Food and Drug Administration (FDA) announced on Tuesday a new initiative aimed at making clinical trials more efficient and faster. The effort will begin with real-time data reviews from trials conducted by AstraZeneca and Amgen.
The agency is also soliciting public feedback on a potential pilot program designed to collaborate with companies leveraging artificial intelligence (AI) to enhance various aspects of clinical trials. These include safety monitoring, medication dose selection, identifying safety signals, and improving patient recruitment.
AstraZeneca and Amgen Trials to Pilot Real-Time Data Review
AstraZeneca is currently conducting a Phase 2 trial of its combination therapy for patients with an aggressive form of lymphoma. The trial will take place at two leading institutions: the University of Texas MD Anderson Cancer Center and the University of Pennsylvania.
Amgen, on the other hand, is running a Phase 1b trial focused on a treatment for small cell lung carcinoma. Both trials will utilize a real-time data platform developed by Paradigm Health to streamline data collection and analysis.
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