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 be based on the desired end-in-mind, and may or may not be consistent with current practices. |
-Paula Rowley (Nicola Newton, PHUSE Project Assistant |
)paula@phuse
Status |
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colour | Blue |
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title | Current Status |
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Q22021Survey has been completed and went out to a sample for testing. Hoping to finalise |
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- Draft white paper was reviewed by the PHUSE office and submitted for public review
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the survey and send to a broad audience in Q3 DeliverablesTimelinesWhite 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 |
Jon Haddad | 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 HamiltonProject team review final White Paper | Q2 2023 |
PHUSE Steering Committee & Public Review | Q3 2023 |
Publish White Paper | Q4 2023 |