Hot Topics

The Working Groups quarterly report is now live! These reports highlight the fantastic progress across our projects, featuring key achievements and the exciting work still underway. Explore the complete reports to see how each project is driving innovation and impact.

Revisit the events from this quarter and explore what’s coming up next.

The SDTM ADaM Implementation FAQ Project within the Optimizing the Use of Data Standards Working Group is pleased to announce that all published FAQ’s are now available on the PHUSE Deliverable website. Click here to view the categories of answered FAQs. 

Real World Evidence

We are pleased to announce that Elena Valkanova will be taking over as the new Real World Evidence Working Group Lead.

Elena began her career in clinical research more than 20 years ago, specialising in statistical programming and data analysis across diverse therapeutic areas. Throughout her career, she has contributed to the design, validation and reporting of regulatory deliverables, ensuring accuracy, reproducibility and compliance with global standards such as CDISC. Her early academic research into algorithmic game theory focused on developing randomised and strategy-improvement algorithms for simple stochastic games – a rare class of combinatorial problems that lie in both NP and co-NP and have no known polynomial-time solutions – providing a strong foundation in probabilistic modelling, computational complexity, and optimisation.

Elena now leads collaborative initiatives to develop practical frameworks and implementation guidance for privacy-preserving methods, including differential privacy, federated learning and synthetic data generation. Her leadership centres on building cross-disciplinary resources that integrate statistical programming, machine learning (ML), artificial intelligence (AI) and large language models (LLMs) to enable compliant, scalable and scientifically robust use of real-world data (RWD).

The SEND Industry Feedback Survey Project within the Nonclinical Topics Working Group have published their 2025 SEND Survey, marking a significant milestone as it enters its 10th consecutive year of providing valuable industry insights.

The survey will remain open from 14 November to 3 December. All responses will be collected anonymously.

The results will be presented at the Nonclinical Advance Event 10–12 February 2026 and subsequently published on the PHUSE Archive.

The Cloud Adoption in the Life Sciences Industry Project within the Emerging Trends & Innovation Working Group, has published a new White Paper, Cloud Services: A Framework for Adoption in the Regulated Life Sciences Industry.

This White Paper provides guidance for adopting cloud services in regulated life sciences. It explains how GxP requirements apply to cloud providers and offers a clear framework for planning and executing exit strategies to ensure data integrity, business continuity and compliance.

The Participant Data Return team has published a blog on their recent survey findings. Participant data return is the act of granting clinical trial participants access to the data that was collected about them during a clinical trial. In current clinical trial practice, we take measurements, conduct tests, and perform procedures. The results are reviewed by the investigator and stored by the sponsor, but participants rarely see their own results.

In spring 2025, PHUSE established the Participant Data Return Project, with the aim of highlighting current industry practice and identifying gaps and challenges in implementation to speed industry uptake. As a first action, in summer 2025, we assessed the current state of data return throughout the industry by surveying PHUSE member companies. PHUSE received a total of 14 responses representing 14 companies worldwide.

The published blog summarises findings and next steps for this project team. If you are interested in getting involved please email workinggroups@phuse.global.

The PHUSE Stakeholder Review of ISRCTN Results System Prototype team has completed their system review and documented their feedback.

The International Standard Randomised Controlled Trial Number registry (ISRCTN) recently released information for public review and comment regarding the new registry they are working on, and the results system prototype was open for review until the end of September. 

The PHUSE project team assembled to review the prototype was a diverse group of experts from the PHUSE Data Transparency Working Group. For the purposes of providing feedback, fields were tested but no results submitted. The summary of comments, included in the ISRCTN results system prototype feedback collated from our review at PHUSE can be found in this document.

The PHUSE Stakeholder Review of UK MHRA Clinical Trials Regulation Guidance project within the Data Transparency Working Group has published a new response to a question regarding MHRA Clinical Trials Regulation Guidance.

On 28 April 2025, the UK Parliament and Northern Ireland Assembly approved the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (available via this link). These new regulations introduce changes to the Medicines for Human Use (Clinical Trials) Regulations 2004, which currently govern the regulation of clinical trials of investigational medicinal products (CTIMPs) in the UK.

New guidance has been published by the UK’s Health Research Authority (HRA) to accompany the Medicines and Healthcare products Regulatory Agency (MHRA)’s updated clinical trials regulations, which come into force on 28 April 2026. The guidance explains important points on what will change in terms of processes, legal requirements, and expectations for anyone involved in setting up or delivering clinical trials. External stakeholders who wished to share feedback on the newly published guidance were asked to provide their submissions to the HRA by 10 September 2025.

View the team's response to the updated guidance here and the associated MHRA algorithm document here.

Community Forum: The Causal Roadmap,Targeted Learning and TMLE: What Is That All About?

29 January 2026 at 10:00-11:00 (EST) / 15:00-16:00 (GMT) / 16:00-17:00 (CET)

Information and Registration

The Nonclinical Topics Working Group is excited to announce a multi-day virtual event coming 10–12 February 2026.

More details coming soon!

We’re pleased to announce that the Real World Evidence Working Group will be holding its second multi-day virtual event from 30 September to 1 October 2026.

 Stay tuned for more details and registration information coming soon!