Working Groups Report – Q3 2026

It’s been another successful and productive quarter for the PHUSE Working Groups! Our projects have progressed and provided many opportunities for the community to engage along the way.

We’re kicking things off with a call for your feedback. If you’ve ever read a plain language summary of clinical trial results, the Value of Plain Language Summaries of Trial Results project would love to hear from you. We have some leadership news from the Optimizing the Use of Data Standards Working Group, where we say a heartfelt thank you to Janet Low and welcome Matt Baldwin and Carlo Radovsky to their new roles.

On the publications front, the Data Visualisation and Open Source Technology, Data Transparency and Real World Evidence Working Groups have released new blog posts and white papers covering everything from statistical method comparisons in R and SAS to imaging data anonymisation and real-world data reliability. We also celebrate two projects completing this quarter.

Finally, we look back at a packed events calendar, including the return of our Data Transparency and Real World Data Autumn Events, alongside Community Forums and webinars. We also share what’s coming up next, with several webinars already open for registration.

Thank you to everyone who has volunteered their time and expertise this quarter. Read on to catch up on all the latest!

If you’re looking to get more involved, three new projects are now calling for volunteers

• SEND Implementation User Group

• Real World Data Lineage Implementation Guide

• Best Practices for Informing Benefit-Risk and Communicating Safety Information

If you would like to volunteer or learn more about these projects, email workinggroups@phuse.global.

This quarter saw three of our Working Groups publish the following deliverables:

Data Visualisation & Open Source Technology

The Comparing Analysis Method Implementations in Software (CAMIS) project has published two new blogs:

• Comparison of Tipping Point Analysis (Delta Adjustment)

• Comparison of GLMMs and GEEs for Categorical Endpoints

The two blogs compare implementations of tipping point analysis with delta adjustments and of GLMMs and GEEs for categorical endpoints in R and SAS.

Data Transparency

The Anonymization of Imaging Data project has published a new white paper titled Imaging Data Anonymisation Guideline. This white paper provides practical recommendations for anonymising DICOM imaging data shared with external researchers. It addresses removing identifiable information from both metadata and pixel content while maintaining research value.

The EU CTR Implementation project has published a new white paper titled Protecting Commercially Confidential Information (CCI) While Complying with the European Union Clinical Trials Regulation (EU) 536/2014. The paper provides practical guidance on identifying, managing and protecting CCI in documents disclosed through the Clinical Trials Information System (CTIS), helping sponsors balance regulatory transparency requirements with the protection of legitimate commercial interests. The publication also includes an appendix containing public review comments and suggested edits for strengthening the paper.

Real World Evidence

The Quality and Reusability of Real World Data project has published a new white paper titled Real-World Data Reliability and Integrity: Ensuring Real-World Data is Fit for Use for Regulatory Submissions. This white paper focuses on the usability of real-world data sources for regulatory submission purposes. To assess the fit for use of this data, we need to assess the relevance and the reliability of the data.

• Enhanced Risk-Based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials 

• Quality and Reusability of Real World Data