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 be based on the desired end-in-mind, and may or may not be consistent with current practices. |
| Project Leads | Emails | Mary Nilsson, Eli Lilly | nilsson_mary_e@lilly.com|
|---|---|---|---|
William Palo, Abbvie | |||
Nicola Newton, PHUSE Project Assistant |
| The writing subteam finalised the draft white paper and submitted to the wider project team for review; should be submitted for PHUSE Office review before the end of the quarterQ3 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 White Paper - Recommended Definition of Treatment-Emergent Adverse Events in Clinical Trials' | Q3 2024 |