Open research > Registering and reporting clinical research

When studies finish, it is important that the results are reported and published so those involved, and the wider community interested in the findings, can access them. There are currently no legal requirements around reporting results, but there are good practice expectations. Legislation is being drafted to codify the requirement to share the findings of CTIMPS with participants (or explain why this is not appropriate), in a suitable format, within 12 months of the trial end date (unless a deferral has been agreed).

CTIMPS should declare the end of the trial to the Medicines and Healthcare products Regulatory Agency (MHRA) within 90 days of the end of the trial date and 15 days of the global premature end of the trial. The summary of results should be submitted within 12 months of the end of the study to the clinical trial registry where the CTIMP is registered. If the register 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 (this is the responsibility of the sponsor). 

For all other types of clinical trials and studies, after the research has been completed a final report of the research should be submitted to the Research Ethics Committee. This report should be submitted within 12 months of its end and the research findings should be made accessible to the public and those who took part in research, in a timely manner.

Key definitions

Clinical Trial: A clinical trial compares the effects of one treatment, preventative intervention or diagnostic test with either another, or a control (no treatment/test). According to the HRA, clinical trials include: a clinical trial of an investigational medicinal product, a clinical investigation or other study of a medical device, a combined trial of an investigational medicinal product and investigational medical device, any other trial to study a novel intervention of randomised clinical trial to compare interventions in clinical practice e.g. trials of surgical interventions, radiotherapy, imaging, mental health investigations/therapies, physiological investigations, trials of non-medicinal products or devices or complimentary/alternative therapies. 

Clinical Trials of Investigational Medicinal Products (CTIMPS): Investigational Medicinal Products (IMP) are any medicine that is being tested in a clinical trial for its effectiveness as a treatment or being used as a reference point for the effectiveness of another treatment. They include newly developed drugs and licensed drugs that are being tested against a new condition or in a new formulation. A clinical trial of an investigational medicinal product compares the effects of an IMP against another treatment, or a control.

Read the full list on our definitions page.

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Registering and reporting clinical research