Hot Topics

The Working Groups Q2 Reports have now been published. Take a look at what our Working Groups have been working on this quarter, along with the events that have taken place.

Have you read a Plain Language Summary (PLS) of clinical trial results? The Value of Plain Language Summaries of Trial Results project is seeking feedback to better understand how PLSs are used and how they can be more meaningful and useful to readers.

Responses are anonymous and will help improve the way clinical trial results are communicated to patients, participants, and the broader public. Please do not mention any confidential or sensitive information.

The survey takes just 5–7 minutes to complete.

As part of PHUSE's commitment to open sharing and collaboration, we encourage anyone interested in raising awareness of this initiative to direct colleagues and contacts to the PHUSE website, where the survey is publicly available. The survey has been developed by the PHUSE Plain Language Summaries Working Group to gather broad, community-driven feedback on how clinical trial results can be made more accessible and useful to readers.

The results will be reviewed, and the survey will potentially close in Q4 2026.

The Enhancing the Clinical Trial Risk Assessment Process project within the Risk Based Quality Management Working Group has produced a White Paper ‘Enhancing Clinical Trial Risk Assessment: From Compliance to Quality-driven Collaboration’. This white paper provides practical guidance for transforming clinical trial risk assessment from a compliance-driven activity into a collaborative, quality-focused process. It presents a six-step framework aligned with ICH E6(R3) and E8(R1), helping teams identify Critical-to-Quality factors, manage risks proportionately, strengthen cross-functional collaboration, and leverage AI to improve the consistency and effectiveness of risk management throughout the study lifecycle.

Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 27 August 2026.

The Comparing Analysis Method Implementations in Software (CAMIS) project within the Data Visualisation and Open Source Technology Working Group has published a new Blog titled, Comparison of Tipping Point Analysis (Delta Adjustment).

This blog builds on an earlier topic of reference-based multiple imputation for continuous longitudinal endpoints (Reference-Based Multiple Imputation), a recent PHUSE CAMIS contribution explored the implementation of tipping point analysis with delta adjustments in R and SAS.

The Comparing Analysis Method Implementations in Software (CAMIS) project within the Data Visualisation and Open Source Technology Working Group has published a new Blog titled, Comparison of GLMMs and GEEs for Categorical Endpoints.

This blog discusses a recent PHUSE CAMIS contribution, developed in collaboration with the PSI AIMS SIG, that explored the implementation of generalised linear mixed models (GLMMs) and generalised estimating equations (GEEs) in R and SAS, and compared the software implementations of each method.

The Anonymisation of Imaging Data project within the Data Transparency Working Group 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 the removal of identifiable information from both metadata and pixel content while maintaining research value. Based on industry standards and regulatory guidance, the paper outlines anonymisation approaches, pixel data considerations, and risk-based strategies to support secure, compliant and reproducible data sharing.

The Quality Tolerance Limits – Threshold Setting Methodologies project within the Risk Based Quality Management Working Group is preparing for its upcoming Webinar 'Risk Based Quality Management Webinar: Action Limits as an Early Warning System within a QTL Monitoring Strategy', taking place 1 September 2026 at 10:30-11:30 (EDT) / 15:30-16:30 (BST) / 16:30-17:30 (CEST).

This session will explore how action limits can serve as an early-warning mechanism within QTL monitoring, helping clinical trial teams detect emerging risks sooner, investigate and respond before thresholds are breached, and support more proactive, informed risk-based quality management.

The Data Transparency Working Group is preparing for its upcoming multi‑day virtual event, taking place 15–17 September 2026 at 10:00–12:30 (EDT) / 15:00–17:30 (BST) / 16:00–18:30 (CEST).

The event will focus on the evolving landscape of clinical data transparency, including approaches to data sharing, anonymisation, governance and enabling responsible access to clinical data.

The Real World Evidence Working Group is preparing for its upcoming multi‑day virtual event, taking place 30 September–1 October 2026 at 09:00–11:30 (EDT), 14:00–16:30 (BST), and 15:00–17:30 (CEST).

Join the PHUSE Community to explore the evolving landscape of real-world data (RWD), including its growing role in clinical research and regulatory decision-making. This event will bring together global experts to share insights, practical approaches, and real-world applications of RWD.

Join us on 13 October, 16:00–17:00 (JST) / 08:00–09:00 (BST) / 09:00–10:00 (CEST), for a session exploring real-world evidence (RWE) and data analytics within the PHUSE community. Koichi Yamaguchi (Boehringer Ingelheim) will introduce PHUSE and Tokyo SDE 2026, William Kuan (SAS APAC) will present his award-winning work on building trustworthy RWD analytics platforms, and Yasunari Sadatsuki (AstraZeneca) will revisit RWE-related content from past PHUSE Japan SDEs.

The Real World Data Lineage Implementation Guide, a new Project within Real World Evidence Working Group, is now calling for volunteers. 

This project aims to develop practical guidance for documenting end-to-end data lineage for real-world data (RWD) regulatory submissions. While FDA and EMA guidance emphasise the importance of tracing data from source to submission, there is limited direction on how to document lineage throughout the full data transformation process.

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: Friday 16 October. A project kick-off meeting will be held on Wednesday 21 October at 11:00–12:00 (EDT) / 16:00–17:00 (BST) / 17:00–18:00 (CEST).