| Project Scope |
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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 | |
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| Charles Beasley |
| , Beasley Pharmaceutical and Biotechnology Consulting |
Wei Wang (Eli Lilly)
| Christopher Smith, FDA | christopher.smith2@fda.hhs.gov |
| Nicola Newton, PHUSE Project Assistant |
Draft white paper is progressing.
The goal is to have the white paper ready for Steering Committee Review in Q220222023 |
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Project Closed. |
Objectives & |
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Deliverables |
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| Timelines | |
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Align on next steps | Q2 2023 |