Safety Analytics

Working Group & Project Scope

Working Group Lead

Mary Nilsson

Greg Ball

A collaboration working to improve the content and implementation of clinical trial safety analyses for medical research, leading to better data interpretations and increased efficiency in the clinical drug development and review processes.

Listings for Clinical Study Reports

Mercy Navarro

Nancy Brucken

This project team will create a White Paper with recommendations for listings to include in Clinical Study Reports based on shared learning from cross-industry participants, to address changes in data availability over time.

Analyses and Displays for Laboratory Data (Version 2)

Wei Wang

This project team will create a White Paper with recommendations for analyses 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 White Paper will combine to two method types and update recommendations given the advancement in interactive options.

Analyses and Displays Associated with Hepatotoxicity

Melvin Munsaka

Terry Walsh

This project team will create a White Paper with recommendations for analyses and displays associated with hepatotoxicity, with a focus on Phase 2-4 clinical trials and integrated submission documents.

 
Adverse Event Collection Recommendations
Aimee Basile 
Mary Nilsson

This project team will create a White Paper with recommendations for adverse event collection instructions, with a focus on Phase 2-4 clinical trials.  This White Paper will build upon a White Paper that outlines results from a survey on current practices, indicating variation that can likely be reduced.  Recommendations will be based on the desired end-in-mind, and may or may not be consistent with current practices.

Treatment Emergent Definition Recommendations

Mary Nilsson

This project team will create a White Paper with recommendations for treatment emergent definitions, with a focus on Phase 2-4 clinical trials.  This White Paper will build upon a White Paper that outlines results from a survey on current practices, indicating variation that can likely be reduced.  Recommendations will be based on the desired end-in-mind, and may or may not be consistent with current practices.

 

 

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