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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William Palo |
, Abbvie |
Nicola Newton, PHUSE Project Assistant |
- Survey deadline was extended to February 2022, leading to regulatory agency participation. Survey results have now been finalised and analyses are underway.
Finalise the summaries from the survey results
Kirthi Rangaraju
Q3 2024 |
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Objectives & Deliverables | Timelines |
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White Paper - Recommended Definition of Treatment-Emergent Adverse Events in Clinical Trials' | Q3 2024 |