The Effective Statistician - in association with PSI

RWE and the FDA (Part 1)

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Interview with Josephine Wolfram​
  • RWEs are dependent on actual patient reaction and response data collected through records provided by the healthcare agencies
  • RWEs are viewed differently by statisticians and the FDA which may create friction, especially in the process of having one medication submitted for approval and production.
  • and more...

    • Learn more about effective clinical trials based on dependable evidence and other topics that will help you in becoming an effective statistician. Listen to this episode and share this with your friends and colleagues!

    References:
    • RWD SIG homepage
    • Draft guidance
      • ...more
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      The Effective Statistician - in association with PSIBy Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry
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