Reporting results on ISRCTN under new UK Clinical Trial regulations

 

New requirements

On 28th April 2026, new regulations come into place in the UK. You can find out more about the regulations on the Health Research Authority’s website. 

The regulations have a section on Transparency (see HRA guidance), which covers how the results of Clinical Trials of Investigational Medicinal Products (CTIMPs) in the UK should be reported. 

For a trial which has a completion date on or after 28th April 2026, a summary of the results must be made publicly available in all registries that it has been registered in, within 1 year of the end of the trial. 

For example, if a trial which has been registered on ISRCTN has a trial completion date of 1st May 2026, results must be made publicly available on ISRCTN before 1st May 2027. 

When reporting results, the requirement is to add a summary of the results, as well as to offer to share with participants a summary of the results written in a manner that is understandable to laypersons (a plain English summary) if the trial was submitted after 28th April 2026. The HRA also recommends sharing a lay summary as good practice for trials submitted before this date. 

The summary of results to be published on ISRCTN must consist of the four following sections: 

  • Participant Flow: A flow diagram showing participants involved at each stage of the study (namely enrolment, intervention allocation, follow-up, and data analysis). Please see an example of a flow diagram. 

  • Baseline Characteristics: Table(s) showing demographic data and any clinical characteristics for participants at baseline, as well as any measures assessed at baseline that are used in analysing a primary outcome measure. Please see an example of a baseline characteristics table. 

  • Adverse Events: Table(s) of all anticipated and unanticipated serious adverse events (life-threatening) and other adverse events (non-life-threatening), which will include a description of the adverse event and the number of participants affected. If there were no adverse events associated with your study, then please include a statement to the effect of “There were no adverse events associated with this study.” 

Interim process for reporting results on ISRCTN

ISRCTN is developing a Results Reporting System to enable you to report your results in a standardised format that meets WHO requirements (see our prototype).

As an interim process ahead of the Results Reporting System launch, to report your results to ISRCTN and add them to your clinical trial record, we need two separate files – your summary of the results (containing the four sections listed above), and your plain English summary of the results. 

If you haven’t already uploaded an up-to-date protocol (see the SPIRIT website for recommendations and standards) for your trial, you will need to also do this at the same time, as well as links to any results publications you have already published, as these also form part of the summary of results. 

You can submit your files to be uploaded to your record by either: 

  • Emailing info@isrctn.com with your files and the details of the trial record they relate to 

Please note that the file upload process on the Report Your Results page is not instantaneous and requires manual oversight from the editorial team, so results will not appear straight away.  

For an example of a clinical trial record which contains results, a plain English summary of results, and a protocol, please see ISRCTN1062149. 

Tips to bear in mind when reporting your results

  • We recommend uploading or emailing your files as PDFs 

  • The results summary and plain English summary of results must be uploaded as two separate files 

  • Your results must only include the four sections listed – Participant Flow, Baseline Characteristics, Outcome Measures and Adverse Events. No other sections should be included. 

  • All the outcome measures reported in the trial record registered must be reported in the results 

  • Ensure the results are emailed or uploaded at least 2 weeks before the 1-year deadline for making results public, in case any changes are required. Allow additional time around UK public holidays. 

  • If your study is registered in multiple registries, results will also need to be added to those as well 

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