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Adaptive Clinical Trial Designs: US FDA Provides Checklist To Begin Study

  • ID: 4775416
  • Report
  • Region: United States
  • 3 pages
  • Datamonitor Healthcare
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Learn more about the September 2018 updated draft guidelines issued by the US FDA for adaptive clinical trials. These new draft guidelines now include examples of clinical trials using adaptive designs, as a means of highlighting the advantages of the adaptive trial structure. This update also contains details on documentation required for FDA evaluation of both the adaptive trial design and completed trials. Additionally, FDA guidance on trials that simultaneously evaluate more than one investigational drug or cancer type within the same trial was issued on the same day. Find out more about both updates in Adaptive Clinical Trial Designs: US FDA Provides Checklist To Begin Study.
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