MHRA pledges two-week review for low-risk clinical trials

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has implemented one part of its plan to reform the regulations governing clinical trials, namely an initiative to cut the time it takes to review low-risk studies in half.

The notification scheme stems from the agency’s overhaul of rules announced in March, with the aim of making it “faster and easier” to gain approval and to run clinical trials in the UK – and elevate the country’s position in the global clinical research sector.

The new objective is to approve the lowest-risk phase 3 and 4 trials in less than 14 days, rather than the current statutory limit of 30 days, provided the sponsor can meet various criteria. For now, it does not apply to first-in-human, phase 1 and 2 studies, or amendments to an existing application.

In the case of a phase 3 trial, the protocol should either have already been approved in the US or EU, follow an earlier phase 3 study of the same drug cleared by the MHRA in the prior two years (as long as various other conditions are met), or involve a drug licensed and used in the UK, EU or US.

For phase 4 studies, the drug under study must be licensed and used according to its approved indication in the UK, EU or US and have no other ongoing safety concerns, such as a clinical hold on other ongoing studies.

“Clinical trials regulation should be flexible and risk-proportionate so that the regulatory requirements are geared to the risk that a trial presents,” according to Dr June Raine, MHRA chief executive.

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

The MHRA estimates that about 20% of UK initial clinical trial applications could be eligible for the scheme.

An opinion from a research ethics committee would remain a requirement for eligible trials, and Dr Janet Messer – director of approvals at the Health Research Authority (HRA), which runs the Research Ethics Service (RES) for NHS studies – said the organisation would explore how that can be used to complement the new initiative.

The scheme has been welcomed by industry, with the BioIndustry Association’s CEO Steve Bates saying it will “provide a timely and effective service to the life sciences sector.”

The UK has traditionally been a stronghold for clinical research, but pressure on the NHS and a slower-than-expected recovery after the pandemic have raised red flags about the long-term health of the sector, threatening the government’s vision of making life sciences a pillar of the national economy.

The move comes after an independent review of the UK’s commercial clinical trials sector – commissioned in the wake of an industry report that found a 41% decline in new study starts between 2017 and 2021 – identified a long list of recommendations to reverse the trend.

One problem highlighted in the report was the lengthy and bureaucratic process for set-up and approval of trials compared to other countries.