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FDA Launches First Real-Time Clinical Trial Pilot With AstraZeneca and Amgen

The pilot gives FDA reviewers cloud-based access to pre-set trial signals in real time to cut long pauses in drug development.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
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Stock photo of blue and red pills arranged in a pattern on a bright yellow background
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Overview

  • The agency, which unveiled the effort Tuesday, began live monitoring with AstraZeneca’s Phase II TRAVERSE trial, with Amgen’s Phase Ib STREAM now in site selection.
  • The FDA has already received and validated live safety and efficacy signals from TRAVERSE through Paradigm Health’s real-time data platform.
  • Reviewers will see pre-defined safety events and clinical endpoints as they occur while sponsors keep individual patient records, which protects privacy.
  • TRAVERSE is running at MD Anderson and the University of Pennsylvania testing acalabrutinib with venetoclax and rituximab for untreated mantle cell lymphoma, while STREAM studies tarlatamab in limited-stage small cell lung cancer with sites still being chosen.
  • An RFI is open for a broader summer pilot with comments due May 29, final criteria in July, and participant selections in August as part of an AI-driven push to trim the 45% administrative ‘dead time’ the FDA says slows drug development.