Significant regulation overhaul sees clinical trial approvals streamlined

6 min read

The Medicines and Healthcare products Regulation Agency (MHRA) is introducing a new series of measures to make it faster and easier to gain approval and to run clinical trials in the UK.

The new framework, published last week, is said to be 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 trial application processes in the 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.

Health and Social Care Secretary Steve Barclay said: “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 treatment including cancer vaccines.”

The changes follow a public consultation, which ran from January to March 2022, in which responses from the public and research community were invited. Brain Tumour Research fed into the consultation process and welcomes change which we hope will mean more brain tumour patients are able to access more clinical trials.

Hugh Adams, Head of Stakeholder Relations, said: “With currently only 5% of brain tumour patients entering the limited number of trials available, any route to improvement is welcome. It is also vital that there is equity of access and there needs to be a UK database highlighted and readily accessible to all clinicians across the UK, with clearly defined and regularly updated eligibility criteria and location information.”


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