Publication of clinical trial results
From 28 April 2026, sponsors of clinical trials of investigational medicinal products (CTIMPs) need to publish a summary of results within 12 months of the end of the trial.
This 12 month timeframe also applies to paediatric CTIMPs. The only exception is if sponsors have a deferral or waiver.
Although the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 requires sponsors to publish a summary of results for their trial, there is not a legislative requirement to publish interim results for the trial.
Which trials this requirement applies to
If a sponsor submitted an application for clinical trial authorisation and an ethics committee opinion for a CTIMP before 28 April 2026 and its end of trial date was before this date, this requirement does not apply. However, it’s still considered best practice to publish trial results.
If a sponsor submits a CTIMP application from 28 April 2026, or it’s submitted before then but its end date is after 28 April 2026, the sponsor must publish a summary of the trial results. An exception to this is if the trial does not recruit any participants in the UK within 2 years and the approval lapses. In this case, the sponsor is not expected to publish summary results for the trial.
You should publish your summary results within these timeframes in the public register (or registers) where you have registered your clinical trial.
If the register used does not have a results section, the results should be posted on a free-to-access, publicly available, searchable institutional website of the sponsor, funder or chief investigator.
Where the main findings are also to be submitted for publication in a journal, this should be done within 12 months of study completion, to be published through an open-access mechanism in a peer-reviewed journal.
Plain language summaries of research findings
Information about research findings should be available to those who took part in the study, interested groups or communities and the general public in a format that is accessible and easy to understand. As part of the HRA’s transparency strategy we ask research sponsors to include a plain language summary of their findings in their Final Report which will be published on our website alongside the study research summaries.
See further guidance on writing a plain language (lay) summary of your research findings.
Information to participants at the end of a study
Providing participants with a summary of the findings acknowledges and appropriately respects the contribution they have made. Information about the publication and dissemination arrangements should be included in the participant information sheet. See our guidance on writing a plain language (lay) summary of your research findings.
Involving patients or other people with relevant experience at an early stage in your planning will help you to provide feedback and dissemination of the study results in a user-friendly way which is accessible to multiple audiences.
We are committed to supporting and encouraging researchers to involve patients and the public in their work at the earliest opportunity. See our public involvement pages for more information on how public involvement can improve the quality and relevance of your research.
You can also visit our informing participants guidance.