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 |
|---|---|
Mary Nilsson |
, Eli Lilly |
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
Q2 2024 |
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Objectives & Deliverables | Timelines |
|---|---|
Project team review final White Paper | Q2 2023 |
| PHUSE Steering Committee & Public Review | Q3 2023 |
| Publish White Paper | Q4 2023 |