[Withdrawn] Registration of clinical trials for investigational drugs and publication of summary results

[Withdrawn] Registration of clinical trials for investigational drugs and publication of summary results

Registration of your clinical trial

Actions for people involved in clinical trial registration

You should use existing and established international registries such as ISRCTN RegistryWhere ClinicalTrials.gov, to make sure the public is aware of your trial. For trials involving both UK and European sites, a record in EU Clinical Trials Register will exist (other than phase 1 studies in adults).

In the United Kingdom, any favorable opinion issued by a research ethics committee is subject to the condition that the clinical trial be registered in a database accessible to the public. Registration must take place before the recruitment of the first participant and no later than six weeks after the recruitment of the first participant. That hasn’t changed. You should continue to include the registry number, if available, in the integrated search request system (IRAS) when preparing your application.

If a sponsor wishes to request a deferral of study enrollment within the required time frame, in accordance with applicable transparency rules (e.g. due to commercial sensitivity), they should contact the Health Research Authority (HRA) to [email protected]

The UK makes information about trials conducted in the UK available to the public, patients, researchers and clinicians through the HRA research abstract site and United Kingdom “Be part of the research” website.

Publication of test results

The deadline for publication of the summary of results is 6 months after the end of the trial for pediatric clinical trials or one year after the end of the trial for non-pediatric clinical trials.

Actions for those who publish the results

You must publish your summary results within these deadlines in the public registry(s) where you registered your clinical trial.

You also do not need to submit this clinical trial summary report to the MHRA; however, you must send a short confirmation email to [email protected] once the results information has been uploaded to the public register and provide a link. If your clinical trial is not on a public register, summary results must be submitted to the MHRA.

You must also submit a final report to the Research Ethics Board within the same timeframe as for the submission of the summary of findings.

Future requirements

We will communicate in more detail on any longer-term requirements for trial registration and notification.

Recording of the clinical trials webinar that took place on October 21, 2020:

Recording of the clinical trials webinar that took place on October 21, 2020

For more information, please email our Customer Service Center at [email protected] or call 020 3080 6000. You can also email [email protected] .uk for urgent matters. You can also contact your trade association by emailing:

Jacob L. Thornton