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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 /wiki/spaces/WEL/pages/220168194 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 /wiki/spaces/WEL/pages/220168194 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.