On the 21st March 2023, following a public consultation with the Health Research Authority and the Department of Health in Northern Ireland, the UK government published a press release on the future regulation of clinical trials with an intention to make it easier and faster to run clinical trials in the UK.
Under the new measures the clinical trials application process in the UK will be more proportionate, streamlined and flexible without compromising on safety with the intention of helping to cement the UK as an attractive destination for trials, including global “multi-site” trials. This will include the integration of the regulatory and ethics reviews of clinical trial applications, which in pilot phase halved the approval times for studies and cut the time from application to recruiting a first patient by 40 days, will be embedded into the new regulation. In addition, the Medicines and Healthcare products Regulatory Agency (MHRA) will also implement a timeline for completion of an application review within a maximum 30 days in general, with a maximum 10 calendar days for a decision to be granted once the regulator has received any final information.
There will also be an increase in transparency with the framework introducing a legal mandate to register the trial in a World Health Organisation (WHO) public register, and a requirement to publish a summary of results within 12 months of the end of the trial. Sharing trial findings with participants in a timely manner and suitable format will also be required by law.
Medilink North of England welcomes these developments that will streamline the clinical trial process and also improve the transparency and credibility of running clinical trials in the UK.
Patrick Trotter, PhD MBA (TechMgmt), Head of Innovation, Commercialisation and Regulatory
The press release can be found here.
The Government response to the consultation can be found here.