Interactive Analyses and Displays for Laboratory Data

This project focuses on the development of interactive analyses and displays for laboratory data in Phase II to III clinical trials and integrated submissions. Interactive outputs provide a more flexible and user-friendly approach to reviewing laboratory data, enabling users to explore results without significantly increasing submission volume. 

The initiative will define key features and best practices for interactive tools, ensuring they are fit for regulatory review and aligned with user needs. It also recognises that multiple groups are independently developing interactive solutions, creating an opportunity to align efforts and promote consistency. 

In addition to defining desired functionality, the project will include educational materials to support interpretation and effective use of these analyses and displays. The resulting deliverable will provide guidance that supports improved data review, enhances usability, and advances the adoption of interactive approaches across the industry. 

Chris Smith, FDA

christopher.smith2@fda.hhs.gov

Nicola Newton, PHUSE Project Coordinator

nicky@phuse.global