The Effective Statistician - in association with PSI

Patient-reported outcomes and the FDA Patient-Focused Drug Development Guidance


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Interview with Rachael Lawrance

Stay tuned as we also talk about the following points:

  1. What's in the 4 guidelines
  2. What factors should be considered when constructing COA-based endpoints?
    • Effect of disease type (e.g., acute, chronic) on endpoint selection – acute symptoms resolve within weeks
    • Treatment objective (e.g., cure, symptom management)
  3. Population
  4. Endpoint
  5. Intercurrent Events – What can affect your measurements interpretation
  6. Population level summary - What Is the Final Way All Data Are Summarized and  Analyzed?

References:

  • FDA Patient focused drug development guidance
  • PFDD Guidance 4 workshop discussion document
  • Public Workshop (Dec 2019)
  • Meeting slides

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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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