Implementing the New UK Clinical Trials Regulations

01/07/2025

The Health Research Authority (HRA) announced that England and Wales have begun implementing changes to their clinical trial regulations on June 1st, 2024. These changes include the removal of the requirement for trials to submit annual progress report to their Research Ethics Committee (REC) and the process of submitting safety reports. Scotland and Northern Ireland, following review, also implemented these changes to their regulations making the updates now applicable in all four of the UK nations as of August 1st, 2024.

  • Annual Progress Reporting

    • Previously, the regulations required annual progress reports for all trials that were expected to be at least two years in duration. However, an estimated 70% of trials in England were not submitting these routine reports. This lack of conformity along with feedback from sponsors led to the requirement being removed which eases the administrative burdens on the trial. It is recommended that trials submit annual reviews to the Confidentiality Advisory Group (CAG) in order to ensure patient confidentiality is being upheld and it also allows for registries to maintain accurate records of ongoing trials. It is still a requirement that trials report any changes that affect the ethics of the initial application in the form of an amendment.  

  • Suspected Unexpected Serious Adverse Events (SUSAR) and annual Safety Reports

    • The regulations still require fatal and life-threatening SUSARs to be reported to the Medicine and Healthcare products Regulatory Agency (MHRA) as well as the REC as soon as possible following the event. SUSARs and annual safety reports which were approved by combined review should only be submitted to the MHRA. If The MHRA determines that the SUSAR requires further action they will instruct the trial team to submit a substantial amendment to their REC. Other SUSAR and annual safety reports submitted to the HRA will only be acknowledged through email instead of signing and returning the report, this also eases administrative burdens on the trial.

HRA guidance have since been updated to reflect the changes made and the HRA themselves are monitoring the impacts of the changes on trial staff, REC members, and applicant. For supplementary information on these changes please see the following link: https://content.govdelivery.com/accounts/UKNHSHRA/bulletins/3ab6e0e.

-The Clinical Pathways Team

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