Working Group Report – Q4 2024

Six of the Working Groups have expanded, with four new projects this quarter: 

• Developing Predictive Models to Facilitate Interpretation of Toxicology Study Results
• Missing Data Imputation in RWD Exploration of Multiple Techniques on Open-Source Data
• Teal Enhancements for Cross-Industry Adoption
• Enhancing the Clinical Trial Risk Assessment Process
• Enhanced Risk-based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials
• End to End RBQM Education

There are two new Projects within Safety Analytics Working Group coming out in the New Year!

• AE Groupings in Safety (AEGiS)
• Best Practices in Data Standards Implementation Governance 
• Treatment Emergent Definitions Recommendations

We have four more published deliverables. The published deliverables this quarter are:

Data Visualisation & Open Source Technology

Comparing Analysis Method Implementations in Software (CAMIS)

• The Comparing Analysis Method Implementations in Software (CAMIS) project under the Data Visualisation & Open Source Technology Working Group have just published a blog titled "A Story from the Novartis Hackathon: Industry Acceptance of the CAMIS Project". This blog talks about the CAMIS project and their involvement atthe Novartis Hackathon. 

Optimizing the Use of Data Standards

Best Practices in Data Standards Implementation Governance

• The Best Practices in Data Standards Implementation Governance project within the Optimizing the Use of Data Standards Working Group has published a new white paper. This white paper presents the results of the survey along with feedback from informal discussions at PHUSE’s Computational Science Symposium (CSS) sessions in 2022 and 2023. The data and observations shared are intended to inform industry and identify further projects for exploration while also encouraging industry collaboration for areas which are found to be the most challenging.

SDTM ADaM Implementation FAQ

• The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published a 5 new FAQ! You can see all the FAQ's this project has answered so far via here.  

Safety Analytics 

AE Groupings in Safety (AEGiS)

• The AE Groupings in Safety (AEGiS) project within the Safety Analytics Working Group has published a new white paper. This white paper outlines why using standard AE groupings for queries is key to understanding a drug’s safety profile, discusses assumptions underlying the use of standard queries for estimation and outlines the benefits of standard queries when available. When standard queries are not available, but detailed analysis of a specific medical condition is needed, this document recommends a process to develop and maintain a custom query that can be replicated by regulatory authorities. 

Treatment Emergent Definitions Recommendations

• The Treatment Emergent Definitions Recommendations project within the Safety Analytics Working Group has published a new White Paper, 'Recommended Definition of Treatment-Emergent Adverse Events in Clinical Trials'. This White Paper defines treatment-emergent events in Phase I to IV clinical trials and integrates summary documents across therapeutic areas. The recommendations described herein were based on the authors' collective experiences and a survey conducted by the PHUSE Treatment Emergent Definitions Recommendations project team to solicit input from respondents on various TEAE scenarios for a simple clinical study design. 

• The Analyses & Displays for Hepatotoxicity  White Paper is out for public review.
• The Management of ODS Regulatory Referenced Deliverables  two Templates were updated and shared for public review, and the team is continuing to work through the feedback.