Analyses & Displays for Laboratory Data

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. 

Charles Beasley, Beasley Pharmaceutical and Biotechnology Consulting

charlesmbeasleyjr@msn.com

Christopher Smith, FDA

christopher.smith2@fda.hhs.gov

Nicola Newton, PHUSE Project Assistant

nicky@phuse.global

Project Closed.

Align on next steps 

Q2 2023