PHUSE Stakeholder Review of ISRCTN Results System Prototype

Background Overview

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 key principles of this results system is to comply with the World Health Organisation data requirements and UK clinical trial regulations, making results submission as easy as we can and provide flexibility for different study designs. Also to help researchers submit accurate and complete data, along with ease of access to this information and re-using the results.

Our Collective Purpose to Connect, Share, Advance

PHUSE has established itself as a key industry voice to regulatory agencies and standards organisations, including the FDA, EMA, and CDISC. We highly value these partnerships. Our global community comprises subject-matter experts from diverse areas within healthcare, and participation in this initiative presents a valuable opportunity to help shape the future of clinical trials.

ISRCTN will use the feedback you share to implement all necessary revisions to the results system prototype. The more feedback we receive, the better the evolution process for this system. Diverse opinions are encouraged and will play a key part in shaping the clinical trial registration process.

Making a Difference to Drive Forward the Clinical Trial Landscape

Making a Difference to Drive Forward the Clinical Trial Landscape

Building upon our successful submission to provide feedback on new guidance to accompany the MHRA’s updated clinical trials regulations and how it is written, this PHUSE project seeks to obtain and collate stakeholder feedback regarding the ISRCTN results system prototype ahead of the deadline to provide comments (PHUSE submission to ISRCTN due end of September 2025). All responses will be anonymous. There will also be opportunities throughout the review period to join an open discussion about providing flexibility in the way members share their feedback.

Project Leads	Email
Devaki Thavarajah, Independent	devaki.thavarajah@phuse.global
Lucy Marks, PHUSE Senior Project Coordinator	lucy@phuse.global

Current Status (Updated Quarterly)
Feedback collected and submitted to ISRCTN

Objectives & Deliverables	Timelines
ISRCTN feedback.	September 2025