Hot Topics
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 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. |
Working Group Q3 Reports |
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The Working Groups quarterly report is now live! This report showcases the incredible progress across our projects, spotlighting key achievements and the exciting work still underway. Dive into the full report to explore how each project is driving impact and innovation. Plus, check out a detailed breakdown of the events that have shaped this quarter’s journey. |
Nonclinical Advance Event – Save the Date |
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The Nonclinical Topics Working Group is excited to announce a multi-day virtual event coming February 2026. More details coming soon! |
RWD Autumn Event – Save the Date |
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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! |
If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. |
Working Group Report: Includes project updates, recent and upcoming deliverables and future plans for each Working Group. | |
Monthly Mailings: The monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE. | |
PHUSE Blogs: Fancy a quick read? A blog is a perfect way to catch up on all things Working Groups. Get the lowdown on the latest events from across the globe and stay updated on industry topics brought to you by industry professionals. |
Initiate and lead a new project under the PHUSE Working Groups umbrella. The new project must address problems of significant relevance to computational science related to drug, biological and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements:
New projects can be submitted anytime during the year, click here to submit. |