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FDA Announces Major Steps to Implement Real-Time Clinical Trials | FDA

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The .gov means it’s official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. FDA NEWS RELEASE Agency unveils real-time trial proofs-of-concept and upcoming pilot program More Press Announcements The U.S. Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT). First, the agency unveiled the successful initiation of two proof-of-concept clinical trials that will report endpoints and data signals to the agency in real time. Second, the agency released a Request for Information (RFI) regarding a proposed pilot program for RTCT that will launch this summer. Early-phase clinical trials are a bottleneck in drug development, often characterized

More Press Announcements For Immediate Release: April 28, 2026 On May 27, 2026, the FDA posted a notice in the Federal Register extending the comment period for the Request for Information until June 29, 2026. The U.S. Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT). First, the agency unveiled the successful initiation of two proof-of-concept clinical trials that will report endpoints and data signals to the agency in real time. Second, the agency released a Request for Information (RFI) reg

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