| 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 | |
|---|---|
| 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 |
|---|---|
White Paper (initial scope) | Q3 2022 |
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|---|---|---|---|---|---|---|
Align next steps for this project in Q1 2023 |
| Project Members | Organisation |
|---|---|
| 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 |