The UK has implemented significant changes to its clinical trials regulation, the biggest overhaul in over 20 years, to make the country a top destination for clinical research while prioritising patient safety. The changes include a more streamlined and flexible application process without compromising safety and will reduce approval times and timelines for decisions. The regulatory framework will be future-proof and supportive of innovative trial designs such as decentralised trials, as well as the completion of global “multi-site” trials.
Transparency is also a key feature of the changes. The framework introduces 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 and suitable manner will also be required by law.
The changes were made in partnership with the Health Research Authority and the Department of Health in Northern Ireland, with input from the public and the research community. New guidance will be introduced to accompany the legislative measures, ensuring that 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.
Health and social care secretary Steve Barclay has emphasized that the changes will speed up clinical trials while encouraging the development of new and better medicines for patients, making the UK an even more attractive place for scientists and researchers to work. The changes are aligned with the government’s vision for the future of UK clinical research delivery, aiming to make the UK a world leader in efficient and cutting-edge clinical research.
