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 |
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Mary Nilsson (Eli Lilly) | |
William Palo (Abbvie) | |
Katie Warren (PHUSE Project Assistant) | katie@phuse.global |
Objectives & Deliverables | Timelines |
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Finalise the summaries from the survey results | Q22022 |
Begin draft White Paper | Q22022 |
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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. |
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 | ||
Kirthi Rangaraju | Pfizer | ||
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 | ||
Shraddha Ganoo | ICON plc | ||
Simin K Baygani | Eli Lilly | Shraddha Ganoo | ICON plc|
Tejas Patel | Booz Allen Hamilton |