UK announces biggest clinical trial overhaul in 20 years
Posted on the 31st March 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a string of changes.
The agency claims the changes will make it faster and easier to gain approval and run clinical trials in the UK.
It is hoped the new regulatory framework will stem a decline in clinical research initiated in the UK and cement it as a destination for future international trials.
Under the new framework, it is reported the clinical trials application processes in the UK will be more proportionate, streamlined and flexible without compromising on safety.
The MHRA will also implement a timeline for completion of an application review within a maximum of 30 days in general, with a maximum of 10 calendar days for a decision to be granted once the regulator has received any final information.
The legislative changes should result in a regulatory framework that is as future-proof as possible, responsive to different types of trials and innovative designs, and supportive of new ways of carrying out trials such as decentralized trials.
The proposed revisions will integrate regulatory and ethics reviews of clinical trial applications. A pilot scheme showed that this halved the approval time for studies and cut the time from application to recruiting a first patient by 40 days.
They will also see the introduction of a legal mandate to register the trial in a World Health Organization (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.
The changes follow extensive public consultation and have been co-designed with stakeholder groups to ensure that future UK clinical trials work in partnership with patients and the public, and are representative of the diversity of people who may benefit from the medicine following regulatory approval.