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Clinical trial regulation set for biggest overhaul in 20 years

A series of new changes to the regulation of clinical trials are set to be implemented by the Medicines and Healthcare products Regulatory Agency (MHRA) in a move that will streamline the approval for, and launch of, medical studies up and down the country.

Under the new practice, the application process for clinical trials will be changed, making it more proportionate and flexible – without compromising on safety.

This will include the full integration of the pilot regulatory and ethics reviews, which initial findings show have halved the amount of time it takes to get approval for a study, as well as reduce the time from application to the recruitment of the first patient by 40 days.

The MHRA will also introduce a general timeline of completion for an application process of 30 days, coupled with a maximum 10-day limit on the amount of time it takes to grant a decision once the regulator has received all the information it needs.

In a bid to boost transparency, the new framework will set a legal requirement to register any trial in the World Health Organization public register, alongside a further mandate to publish a summary of the results within 12 months of a study’s completion as well as another requirement to share results with participants in a timely and appropriate manner.

The updated measures come after a public consultation in collaboration with the Health Research Authority (HRA) and Northern Ireland’s Department of Health, and represent the most comprehensive reform of UK clinical trial regulation in two decades.

Chief Science and Innovation Officer at MHRA, Marc Bailey, 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.”

HRA’s Chief Executive, Matt Westmore, added: “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.

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NHE May/June 2024

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