The Medicines and Healthcare products Regulatory Agency (MHRA), with support from its partners, is introducing a series of new measures designed to streamline the approval and running of clinical trials in the UK. This initiative marks the most significant overhaul in UK clinical trials regulation in over two decades, aiming to position the UK as a leading destination for clinical research.
Under the new framework, the application processes for clinical trials will become more proportionate, streamlined, and flexible, without compromising on safety. A notable change includes the integration of regulatory and ethics reviews, which during its pilot phase, halved approval times and reduced the time from application to recruiting the first patient by 40 days.
The MHRA will also enforce a timeline for application review completion within a maximum of 30 days, with a decision to be granted within 10 calendar days after receiving any final information. These legislative changes aim to create a regulatory framework that is future-proof, responsive to various types of trials, and supportive of innovative trial designs, such as decentralized trials.
Transparency will be enhanced through a legal mandate to register trials in a World Health Organisation (WHO) public register and a requirement to publish a summary of results within 12 months of the trial's conclusion. Additionally, sharing trial findings with participants in a timely and suitable format will be legally required.
These reforms follow a public consultation conducted in partnership with the Health Research Authority (HRA) and the Department of Health in Northern Ireland. Comprehensive new guidance, developed in collaboration with stakeholder groups, will accompany the legislative measures to ensure clinical trials are inclusive and representative of the diversity of potential beneficiaries.
Marc Bailey, MHRA Chief Science and Innovation Officer, emphasized the importance of flexible and agile regulation, highlighting the success of the UK's COVID-19 approvals. Matt Westmore, HRA Chief Executive, and Health and Social Care Secretary Steve Barclay also expressed their support for the reforms, noting their potential to accelerate clinical trials, develop better treatments, and cement the UK's position as a life-science superpower.
The legislative changes align with broader efforts to make the UK a science superpower, supported by additional funding and a coordinated program of work aimed at the recovery, resilience, and growth of UK clinical research. This initiative is part of the government's vision for the future of UK clinical research delivery, aiming to make the UK world-leading in efficient and cutting-edge clinical research.
