| Project Scope |
|---|
This project team will create a users guide or White Paper with recommendations for analysis 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 |
Wei Wang (Eli Lilly)
| Christopher Smith, FDA | christopher.smith2@fda.hhs.gov |
| Nicola Newton, PHUSE Project Assistant |
Objectives & Deliverables
White Paper (initial scope)
|
|---|
Final White Paper (initial scope) has been designed and is currently being reviewed by the project team before publishing.
Q3 2023 |
|---|
Project Closed. |
Objectives & Deliverables | Timelines |
|---|---|
Align on next steps | Q2 2023 |
Thanabalasundrum