A series of new measures will be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) with support from partners to make it faster and easier to gain approval and to run clinical trials in the UK.
These changes represent the biggest overhaul in UK clinical trials regulation in over 20 years and will help to make the UK one of the best countries in the world to conduct clinical research for patients and researchers.
Under the new framework, clinical trials application processes in UK will be more proportionate, streamlined and flexible without compromising on safety, helping to cement the UK as an attractive destination for trials, including global “multi-site” trials. For example, 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.
Marc Bailey, MHRA chief science and innovation officer, said: “Our world-first COVID-19 approvals showed how important it is to ensure that regulation is flexible and agile. This overhaul of the clinical trials legislation will do just this – it will move us away from a one-size-fits-all approach to the regulation of clinical trials and help to streamline approvals by removing granular and duplicative regulatory requirements.
“This will make the UK one of the best countries in the world to conduct clinical research and, get innovative medicines to the people who need them faster.
“We will now work collaboratively with patients and the research community to ensure these changes are implemented as quickly as possible.”
The 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. The legislative changes will 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 decentralised trials.
On transparency, the framework will introduce 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.
These changes, which follow a public consultation in partnership with the Health Research Authority (HRA) and the Department of Health in Northern Ireland, have been made possible with the help of the public and the research community.
Matt Westmore, HRA chief executive, said: “Today’s response is a clear and exciting opportunity to ensure that clinical trials will speed up diagnosis, help develop better treatments and enable the NHS to deliver world-class care, as well as cementing the UK’s position as a life-science superpower.
“We’re delighted that the responses to the consultation give us a strong mandate to continue our work to streamline regulation and support the research community to improve meaningful public involvement. The consultation responses show we are all committed to enabling the highest quality health research which can benefit the whole UK population, and that we are all working towards making it easy to do research that people can trust.”
Comprehensive new guidance, co-designed with these stakeholder groups, will be introduced to accompany the new legislative measures. This will ensure that UK clinical trials truly work in partnership with patients and the public and are representative of the diversity of people who may benefit from the medicine if the data generated ultimately lead to regulatory approval. Included in the guidance will be how to include patients meaningfully into the design and conduct of trials, and how to achieve diversity in trials in a way that is proportionate and achieves the best results.
Health and social care secretary Steve Barclay said: “The UK continues to lead the way in ground-breaking clinical trials and these reforms – the biggest in 20 years – will make this country an even more attractive place for scientists and researchers to work.
“These changes will help speed up clinical trials, without compromising on safety, and encourage the development of new and better medicines for patients. They come after the government announced additional funding of £10 million for the MHRA to accelerate the delivery of cutting-edge treatments including cancer vaccines.”
These legislative changes are aligned with the review of clinical trials led by Lord O’Shaughnessy and work undertaken by Sir Patrick Vallance to make the UK a science superpower. They build on the close collaboration with MHRA over recent years to deliver combined ways of working, reducing the complexity of getting trials approved and up and running.
They also support a wider coordinated programme of work that has been developed to ensure the Recovery, Resilience and Growth (RRG) of UK clinical research, as set out in the Government’s bold vision for The Future of UK Clinical Research Delivery. Through this vision and plan, the research ecosystem across the UK is working together to achieve the aim of making the UK world-leading in efficient and cutting-edge clinical research.
To support the MHRA’s drive to be an innovation-first regulator, HM Treasury announced in the Spring budget that the UK regulator would receive £10 million funding to get innovative medicines to the patients who need them sooner.