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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 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 Optimizing the Use of Data Standards Working Group has submitted its official response to the NIH draft policy on sharing study results.

The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published a new response to a question regarding FASEQ Values for Split Findings About (FA) Domains and Their Implication on ADaM. View the team's response to the following question here.  

‘How should you approach FASEQ in SDTM and ADaM for a Findings About (FA) domain split across datasets?

SDTMIG v3.4 (6.4.2 Naming Findings About Domains) states: “FASEQ must be unique within USUBJID for all records across the split datasets.” Since the FA datasets can be created as independent datasets without first creating and then splitting an overall FA domain, it may be difficult to assure that the uniqueness of FASEQ is maintained across these datasets.  

Within ADaM, SRCDOM denotes the SDTM domain or ADaM dataset that was the source of the variable referred to by SRCSEQ. Although this definition implies that dataset name would be used for ADaM datasets and domain for SDTM domains, using the SDTM domain value 'FA' for SRCDOM along with the value of FASEQ for SRCSEQ would be insufficient to determine which split FA dataset was the SDTM data source.’ 

Do you have a SDTM ADaM Implementation question? Send your questions to the team by emailing workinggroups@phuse.global. 

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 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 (CET)

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 EU Clinical Trials Regulation Results Reporting: Guidance on Results Templates, Interim Analysis Milestones and Submission Format Harmonisation, a new Project within Data Transparency Working Group, is now calling for volunteers. 

The project will focus on three key areas: establishing a common approach to results and scientific summary documents, providing greater clarity around interim analysis dates and milestones, and exploring how current submission formats can be better harmonised.

Building on the completed EU CTR Implementation Project, this work will help sponsors and disclosure teams reduce rework, improve consistency and support compliant results reporting across the industry.

Apply to join via the new member form. Questions? Email workinggroups@phuse.global. Closing date: Friday 4 December 2026.