Working Groups Report – Q4 2025

PHUSE would like to extend our sincere thanks to Parag Shiralkar for his valuable contributions and dedication as the Real World Evidence Working Group Lead. Parag’s leadership and guidance have been instrumental in shaping the group’s progress and advancing key industry discussions.

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 therapeutic areas. 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).

There have been four published deliverables this quarter:

Data Transparency

The Participant Data Return team have published a blog post 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 Patient 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 14 responses representing 14 companies worldwide.

The published blog post 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 project within the Data Transparency Working Group have completed their system review and documented their feedback. 

The ISRCTN recently released information on its new registry and opened its results system prototype for public review until the end of September.

A PHUSE project team from the Data Transparency Working Group reviewed the prototype, testing fields without submitting results. The summary of the PHUSE feedback on the ISRCTN results system prototype is available in this document.

The PHUSE Stakeholder Review of UK MHRA Clinical Trials Regulation Guidance project have published a new response to a question on the updated MHRA Clinical Trials Regulation Guidance.

On 28 April 2025, the UK approved the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, updating the 2004 CTIMP regulations. New HRA guidance has been released ahead of the revised regulations coming into force on 28 April 2026, outlining key changes to processes and requirements for clinical trials. Stakeholders were invited to provide feedback by 10 September 2025. View the team's response to the updated guidance here and the associated MHRA algorithm document here.

Emerging Trends & Innovation

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.

SDTM ADaM FAQ – Deliverable Update

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

• PHUSE Stakeholder Review of UK MHRA Clinical Trials Regulation Guidance

• PHUSE Stakeholder Review of ISRCTN Results System Prototype

• Cloud Adoption in the Life Sciences Industry