Working Group Report – Q1 2025

Working Groups – Q1 2025 Summary

Welcome to the PHUSE Quarter 1 2025 Working Group Report Summary.

It has been a great start to 2025, with new projects being approved, new deliverables and lots of events! We also had an exciting announcement: the Emerging Trends and Technologies Working Group has changed its name to Emerging Trends and Innovation!

Why the change? Working Group Lead Mike Hamidi shares what brought about this change of name and scope:

“The name change from Emerging Trends and Technologies to Emerging Trends and Innovation reflects a broader focus beyond technological enablement. This shift encompasses ongoing developments in areas such as AI/ML, digital health technologies, and healthcare standards and aims to provide deeper insights into these and other evolving topics. This adjustment will preserve the emphasis on emerging trends while enhancing our commitment to delivering valuable industry insights and innovations.”

We are equally excited to welcome Mark Bynens, the new Working Group Lead. Mark joins Mike Hamidi and Stuart Malcolm.

Mark brings a wealth of experience as Director and Scientific Computing Operations (SCO) Head within Statistics & Decision Sciences (SDS), Global Development at Johnson & Johnson. Mark leads initiatives in change management, project management, education, high-performance computing and statistical research.

New Projects This Quarter

Four of the Working Groups have expanded, with seven new projects this quarter:

Emerging Trends & Innovation Working Group: QC Workflow Optimisation
Emerging Trends & Innovation Working Group: The Use of Git in Statistical Programming
Emerging Trends & Innovation Working Group: Integration of Omics Data into Clinical Drug Development
Nonclinical Topics Working Group: SEND Coding Bootcamp
Real World Evidence Working Group: Using OMOP and Other Real World Data Standards to Support Regulatory Submissions
Safety Analytics Working Group: Estimands in Safety Analytics
Process for Aggregate Assessment of Clinical Trial AE Data

Published Deliverables

We have two more published deliverables this quarter:

Optimizing the Use of Data Standards

SDTM ADaM Implementation FAQ

The SDTM ADaM Implementation FAQ project have published a 5 new FAQ this quarter! You can see all the FAQs this project have answered so far here.

Safety Analytics

Analyses & Displays for Hepatotoxicity

The Analyses & Displays for Hepatotoxicity project have published a new white paper!

This white paper provides recommendations for displaying, summarising and analysing measures of hepatotoxicity in tables, figures and listings (TFLs). The suggested TFLs will have implications for what and how liver-related data should be collected. If the data required to populate these TFLs is not collected, then there may be insufficient information to adequately assess the potential for a drug to cause or contribute to the cause of hepatotoxicity.

Under Review

DT WG: The Rare Disease/Small Population Data Sharing white paper is out for public review.

Under Review
Data Transparency Working Group: The Rare Disease/Small Population Data Sharing white paper is out for public review.

WORKING GROUPS

Working Group Report – Q1 2025

Welcome to the PHUSE Quarter 1 2025 Working Group Report Summary.

It has been a great start to 2025, with new projects being approved, new deliverables and lots of events! We also had an exciting announcement: the Emerging Trends and Technologies Working Group has changed its name to Emerging Trends and Innovation!

Why the change? Working Group Lead Mike Hamidi shares what brought about this change of name and scope:

We are equally excited to welcome Mark Bynens, the new Working Group Lead. Mark joins Mike Hamidi and Stuart Malcolm.

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