EU Clinical Trials Regulation Results Reporting: Guidance on Results Templates, Interim Analysis Milestones and Submission Format Harmonisation
Project Description |
This project will develop practical, cross-industry guidance to support consistent reporting of clinical trial results under the EU Clinical Trials Regulation (EU CTR). It will address current challenges caused by limited practical guidance, varying results formats, and differing interpretations of interim analysis dates and milestones. Building on the work of the EU CTR Implementation project, the group will focus on three key areas: developing recommendations for a common structure for results and scientific summary documents, providing greater clarity around interim analysis definitions, and reviewing current submission formats to support greater harmonisation. The project will bring these areas together into a single practical guidance deliverable, helping sponsors and disclosure teams reduce rework, improve consistency, and support compliant results reporting. The work will remain aligned with current EU CTR regulatory expectations and evolving industry practice. |
Project Leads | |
|---|---|
Christa Polidori, Regeneron | |
Sanjay Bagani, Xogene Services | |
Alex Pearce, PHUSE Project Coordinator |
This is a new project currently seeking volunteers. If you are interested in getting involved and contributing to this initiative, please contact Workinggroups@phuse.global. Closing date: Friday 4 December 2026. |