EUPATI tutorial: Reporting and recording clinical trial results

This EUPATI tutorial offers a clear, patient‑oriented yet technically robust overview of how clinical trial results move from internal study documentation to public‑facing outputs. It explains which documents are produced, who can access them and how different audiences (regulators, clinicians, patients and the public) receive information about trial outcomes. The tutorial is hosted in the EUPATI Toolbox as a concise web page with explanatory text and a downloadable PowerPoint presentation that can be reused for training.
The content is structured around the main dissemination channels for trial results:
-Clinical study report (CSR): a detailed, regulator‑facing document prepared by the sponsor in a standard format as part of the common technical document for a marketing authorisation application.
-Regulatory and product information: European public assessment reports and product information (summary of product characteristics and package leaflet), which summarise the evidence supporting marketing authorisation decisions.
-Clinical trial registries: resources such as EudraCT/EU Clinical Trials Register, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov, which present structured protocol information and, in many cases, summary results.
-Scientific publications and conferences: journal articles and conference presentations that communicate results to clinicians and researchers.
-Patient‑focused and public channels: patient organisation websites and news media, which may provide lay summaries or commentary on clinical trial findings.
For researchers, the tutorial provides a practical introduction to the results‑reporting landscape and supports investigators and patient partnrs in planning a dissemination strategy and explaining to participants how and where trial results will be shared.