Image of scientists in a laboratory depicting MHRA's clinical trial overhaul

Low-risk late-stage clinical trials will be approved within two weeks, MHRA says

The NHS and its patients are set to benefit from a new initiative that will see clinical trial approval reduce by more than 50%.

The scheme comes from the Medicines and Healthcare products Regulatory Agency (MHRA) and means that applications for the lowest-risk phase three and four trials will be processed by MHRA within 14 days – rather than the statutory 30.

This is provided the sponsor can show the trial meets MHRA criteria, which includes confirming there are no known safety issues with the medicine being studied.

MHRA expects the new timings to benefit around one in every five clinical trial applications in the UK.

The scheme signals the start of MHRA’s biggest overhaul of regulation in 20 years.

“This will help give UK patients quicker access to the potentially life-saving medicines being studied.”

Chief executive at MHRA, Dr June Raine, said: “We are excited to introduce this new streamlined clinical trials system. Clinical trials regulation should be flexible and risk-proportionate so that the regulatory requirements are geared to the risk that a trial presents.

“Our new notification scheme is exactly that. It will reduce the time taken to get the lowest-risk clinical trials up and running without undermining patient safety.”

The criteria for the scheme has been reviewed and approved by various expert groups, including the Commission on Human Medicines and the Clinical Trials, Biologicals, and Vaccines Expert Advisory Group.

Director of approvals at the Health Research Authority, Dr Janet Messer, commented: “We’re delighted to support the MHRA with this new scheme.

“Combined review has already reduced the time taken to review clinical trials to half what it was five years ago, and we’re keen to explore how the UK’s fast-track Research Ethics Service can complement the new notification scheme to further accelerate high quality health and social care research.”

“Our message to all clinical trial sponsors is that it’s in everyone’s best interest now to use the new scheme for all eligible trials,” added Dr Raine.

Image credit: iStock

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NHE May/June 2024

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