Biggest overhaul of UK clinical trial regulation for 20 years

Clinical trial

A series of new measures will be introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to make it faster and easier to gain approval and run clinical trials in the UK.

These changes represent the biggest overhaul in UK clinical trials regulation in over 20 years and are designed to make the UK one of the best countries in the world to conduct clinical research.

The new framework aims to make clinical trials application processes in UK more proportionate, streamlined and flexible without compromising on safety. For example, the regulatory and ethics reviews of clinical trial applications will be integrated. In the pilot phase, this halved the approval times for studies and cut the time from application to recruiting a first patient by 40 days.

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.

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.

To support this overhaul, the Treasury announced in the Spring budget that the MHRA would receive £10 million ($12.2 million) funding.

Flexible and agile 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.”

New guidance, co-designed with the Health Research Authority (HRA) and the Department of Health in Northern Ireland, will be introduced to accompany the new legislative measures.

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.

Richard Torbett, ABPI Chief Executive, commented on the new framework: “It’s great to see the MHRA taking forward these important changes to UK clinical trials regulation centred on patient safety and the benefits of participating in research. The reforms are a significant step forward for UK clinical trials and come at a crucial time for industry clinical research in the UK.”

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