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Created by Former user, last modified by Former user on Jul 20, 2021
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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. |
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The team are currently developing the scenarios for their survey and are working on an abstract for the EU Connect. |
Objectives & Deliverables | Timelines |
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White Paper with recommended definition(s). | Q42021 |
Project Members | Organisation |
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Alan Shapiro | FDA |
Beilei Xu | Sanofi |
Carolyn Setze | AbbVie |
Cathy Bezek | Astellas |
Charles Beasley | MNS |
Elisa Young | Southern Star Research |
James Gaiser | Prometrika |
Joanne Zhou | GSK |
Jun Li | Sanofi |
Kim Musgrave | Amgen |
Project Members | Organisation |
Laura Goebel | Janssen Research & Development |
Melvin Munsaka | AbbVie |
Meredith Chuck | FDA |
Nancy Brucken | CSG |
Pranab Mitra | Industry |
Raj Phadtare | Corvus Pharma |
Ramaiah Muvvala | Inductive Quotient Analytics |
Robert (Mac) Gordon | Janssen Research & Development |
Russell Newhouse | Eli Lilly |
Simin K Baygani | Eli Lilly |
Tejas Patel | Booz Allen Hamilton |