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 |
Objectives & Deliverables
Finalise the summaries from the survey results
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Survey deadline was extended to February 2022, leading to regulatory agency participation. Survey results have now been finalised and analyses are underway.
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 |