Engaging ICH on TEAE Definition Recommendations
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Problem Statement |
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| The PHUSE white paper on Recommended Definition of Treatment-Emergent Adverse Events in Clinical Trials was a successful first step in attempting to reduce the variability in defining TEAEs across the industry. To further broaden the impact of this work, we would like to propose to ICH that they incorporate this topic into their guidance. |
Project Scope |
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Further standardisation of the TEAE definition and broader communication of the recommendations through ICH will result in wider acceptance of these ideas throughout the industry. While there is no guarantee that ICH will accept this proposal, we feel it is worth the effort given our recent success with the TEAE white paper. This effort should also raise the visibility of PHUSE in the safety analytics space. This project is limited to the work needed to develop and submit the proposal to ICH. Ellis Unger (PHUSE Safety Analytics Co-Lead) and Veronica Pei (FDA) have experience of navigating the ICH process and have offered to assist. |
| Project Leads | Emails |
|---|---|
William Palo, (Volunteer) | |
| Tiffany Davis, Gilead | Tiffany.Davis@gilead.com |
| Nicola Newton PHUSE Project Coordinator |
| Objectives and Deliverables | Timetables |
|---|---|
| TBC |
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