Hot Topics

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 Data Transparency Working Group has submitted its official response to the NIH draft policy on sharing study results.

The response supports clear, accurate and accessible communication of study results to participants, while recommending practical and proportionate guidance across different research settings. Key considerations include plain language summaries, participant accessibility and choice, privacy, clear responsibilities, alignment with established international practices, and appropriate use of technology to support implementation.

The PHUSE Special Projects team has published a new white paper. Titled 'Strategic Use of GenAI in Statistical Programming', this white paper provides a principle-based, inspection-ready framework for adopting generative AI across the end-to-end statistical programming lifecycle. Developed by contributors from across the pharmaceutical industry, the white paper establishes five foundational principles for responsible GenAI adoption.

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

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 Safety Analytics Education project within the Safety Analytics Working Group is preparing for its upcoming webinar, ‘Scientific Evaluation of Safety Data: A Learning and Decision-Making Approach – Safety Estimands’, 10 November 2026 11:00–12:30 (EST) / 16:00–17:30 (GMT) / 17:00–18:30 (CET)

This ASA BIOP Safety Working Group webinar, co-organised with PHUSE and PSI/EFSPI, provides an overview of the ICH E9(R1) Estimand Framework and its relevance to, and application in, the analysis of clinical trial safety data. This webinar will explore how to translate different clinical safety questions into appropriate estimands and align them with corresponding estimators.

The Safety Analytics Education project within the Safety Analytics Working Group is preparing for its upcoming webinar, ‘The Statistician, the Clinician and the Hot Water Heater’, 10 December 2026 9:00–10:00 (EST) / 14:00–15:00 (GMT) / 15:00–16:00 (CST)

A conversation with Janet Wittes and Walter Straus about how statisticians and clinicians need to use mutually understandable language to address complex health problems, drawing lessons from a Legionnaires’ disease investigation and careers of successful collaboration.

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.

Apply to join via the new member form. Questions? Email workinggroups@phuse.global. Closing date: Friday 9 November 2026.