Project Scope This project team will create a users guide or White Paper with recommendations for analysis and displays for Laboratory Data, with a focus on Phase 2-4 clinical trials and integrated submission documents. There have been 2 previous White Papers on this topic (1 for central tendency in 2013 and 1 for Outliers/Shifts in 2015). This paper will combine two method types and update recommendations given the advancement in interactive options. |
Project Leads | |
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Charles Beasley (Beasley Pharmaceutical and Biotechnology Consulting) | charlesmbeasleyjr@msn.com |
Christopher Smith (FDA) | christopher.smith2@fda.hhs.gov |
Katie Warren (PHUSE Project Assistant) | katie@phuse.global |
Objectives & Deliverables | Timelines |
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White Paper (initial scope) | Q3 2022 |
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Align next steps for this project in Q1 2023 |
Project Members | Organisation | ||
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Amelia Pang | Sanofi | Darshan Bhatt | Industry |
Edward Rausch | Eli Lilly | ||
Hongli Lu | Merck | ||
Kirthi Rangaraju | Pfizer | ||
Mary Nilsson | Eli Lilly | ||
Maria Dalton | GSK | ||
Mercy Navarro | Genentech | ||
Miri Kramer | Mediwound | ||
Nancy Brucken | CSG | ||
Nhi Beasley | FDA | ||
Rahal Hamza | IQVIA | ||
Raj Phadtare | Corvus Pharmaceuticals | ||
Robert (Mac) Gordon | Janssen Research & Development | ||
Sumit Pradhan | Industry | ||
Shayami Thanabalasundrum | Eli Lilly | ||
Wei Wang | Eli Lilly | ||
Xuewei (Sherry) Cui | Eli Lilly |