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 |
Paula Rowley (PHUSE Project Assistant) | paula@phuse.global |
Objectives & Deliverables | Timelines |
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Align on next steps | Q2 2023 |
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Project currently on hold |
Project Members | Organisation |
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Amelia Pang | Sanofi |
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 |
Neeta Laddha | Parexel |
Nhi Beasley | FDA |
Rahal Hamza | IQVIA |
Raj Phadtare | Corvus Pharmaceuticals |
Robert (Mac) Gordon | Janssen Research & Development |
Sumit Pradhan | Industry |
Shayami Thanabalasundrum | Eli Lilly |
Song Liu | Novo Nordisk |
Soujanya Konda | IQVIA |
Venkata Dalta | Genmab |
Wei Wang | Eli Lilly |
Xuewei (Sherry) Cui | Eli Lilly |