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The Working Groups' Q3 reports have now been published. Explore the latest updates to see what our Working Groups achieved this quarter, including key project milestones, deliverables, and activities, as well as a summary of events delivered across the PHUSE Community.

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 project 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 Quality and Reusability of Real World Data project within the Real World Evidence Working Group 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. For the purpose of their guidance documents, the FDA defines real-world data (RWD) as data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources.

The EU CTR Implementation project within the Data Transparency Working Group 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. Topics include CCI identification, redaction strategies, disclosure-ready document authoring, CCI library development, and the use of emerging technologies to support disclosure activities. The publication also includes an appendix containing public review comments and suggested edits to help strengthen the paper.

Join us on 13 October 2026 at 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 End to End RBQM Education project within the Risk Based Quality Management Working Group is preparing for its upcoming webinar, 'Medical Writers as Strategic Partners in RBQM', taking place 19 October 2026 at 10:30–11:30 (EDT) / 16:30–17:30 (BST) / 17:30–18:30 (CEST)

This webinar explores the strategic role of medical writers in Risk-Based Quality Management (RBQM), highlighting how early involvement, effective collaboration, and data-driven reporting support quality, compliance, and credible clinical trial outcomes.

The pharmaverse Working Group is preparing for its upcoming Hackathon, ‘pharmaverse Hackathon series featuring the {logrx} package’.

Kick-off · Tuesday 20 October

09:00 EDT  |  14:00 BST  |  15:00 CEST

Hackathon · Thursday 29 October

09:00 EDT  |  13:00 GMT  |  14:00 CET

Wrap-up · Friday 6 November

09:00 EST  |  14:00 GMT  |  15:00 CET

The hackathon focused specifically on {logrx}, an R package designed to support traceable and reproducible clinical programming workflows. It runs R scripts and generates detailed logs capturing code execution, the computing environment, packages and functions used, runtime information, messages, warnings, and errors to support review and reproducibility.

The Safety Analytics Education project within the Safety Analytics Working Group is preparing for its upcoming webinar, ‘Inside the Data Monitoring Committee: Evolution, Myths, and Lessons Learned’, 5 November 2026 10:00–11:30 (EST) / 15:00–16:30 (GMT) / 16:00–17:30 (CET)

Gain insights from Frank Rockhold and Jay Herson as they discuss the evolution of DMCs, address common misconceptions, and share key lessons from their decades of leadership in clinical trial monitoring.

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 2026. A project kick-off meeting will be held on Wednesday 21 October 2026 at 11:00–12:00 (EDT) / 16:00–17:00 (BST) / 17:00–18:00 (CEST).

The Best Practices for Informing Benefit-Risk and Communicating Safety Information, a new Project within Safety Analytics Working Group, is now calling for volunteers.

The project aims to enhance how safety information supports benefit–risk decisions by identifying ways to communicate safety findings more clearly, meaningfully, and transparently. It evaluates how safety data are summarised and contextualised to better reflect the underlying evidence and clinical relevance. The project also considers structured benefit–risk frameworks, estimands, and aggregated safety assessments across studies. Deliverables focus on practical communication principles, illustrative examples, and consensus recommendations that stakeholders can apply directly.

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 23 October 2026. A project kick-off meeting will be held on 28 October 2026 at 9:00–10:00 (EDT) / 13:00–14:00 (GMT) / 14:00–15:00 (CET).

The SEND Implementation User Group, a new Project within Nonclinical Topics Working Group, is now calling for volunteers. 

This initiative aims to establish a centralised industry hub for SEND-related information, bringing together implementation guidance, educational resources, industry updates, and opportunities for community engagement. The project will support a wide range of stakeholders, including SEND users, data providers, software vendors, regulators, CROs, sponsors, and standards organisations.

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: Friday 9 November 2026.