Project Scope |
This Project team will create a White Paper with recommendations for Treatment Emergent Definitions, with a focus on Phase 2-4 clinical trials. This White Paper will build upon a White Paper that outlines results from a survey on current practices, indicating variation that can likely be reduced. Recommendations will bebe based on the desired end-in-mind, and may or may not be consistent with current practices. |
| Project Leads | Emails |
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Mary Nilsson
William Palo, Abbvie |
Nicola Newton, PHUSE Project Assistant |
Survey has been completed but left open for FDA feedback/ participation.
Have a draft completed for Q42022
Kirthi Rangaraju
2024 |
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Objectives & Deliverables | Timelines |
|---|---|
White Paper - Recommended Definition of Treatment-Emergent Adverse Events in Clinical Trials' | Q3 2024 |