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

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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