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PHUSE collaborations are organised into a number of specialist Working Groups, each with a broad topic area. The Working Groups have specific projects designed to achieve a set of particular objectives. This page will highlight the latest news and information from our projects. Participation is open to anyone who wants to contribute and if you would like to get involved, please email workinggroups@phuse.global. |
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Data Transparency |
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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 is 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. |
Data Transparency |
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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. |
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