MHRA unveils big shakeup in UK clinical trials regs

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced sweeping changes to regulations governing clinical trials, which it says are the largest in more than 20 years.

The aim is to make it “faster and easier” to gain approval and to run clinical trials in the UK, in an attempt to shore up the country’s position in the global clinical research sector.

Among the new changes will be a facility to run regulatory and ethics reviews of clinical trial applications in parallel, to reduce the time it takes to get a study up and running, said the MHRA, pointing to a pilot study which found that approach could halve the time from application to recruiting a first patient.

It has also proposed a maximum 30-day period to review new trial applications, and a maximum of 10 days after the receipt of additional requested information.

To boost transparency in clinical research, the plans also include a legally binding requirement to register new trials in a World Health Organisation (WHO) public register, and provide the results within 12 months of the studies’ completion.

The reforms come shortly after the UK Office of Life Sciences (OLS) commissioned an independent review of the country’s commercial clinical trials sector, in the wake of an industry report that found a 41% decline in new study starts between 2017 and 2021.

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.

AstraZeneca suggested earlier this year that one reason for a decision to site a new facility in Ireland, rather than the UK, was reduced access to clinical trial capacity, particularly for late-stage, industry-backed projects.

“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,” promised Marc Bailey, the MHRA’s chief science and innovation officer.

“We will now work collaboratively with patients and the research community to ensure these changes are implemented as quickly as possible,” he added.

The publication of the plans prompted a warm response from industry, with the Association of the British Pharmaceutical Industry (ABPI) calling the MHRA’s move “a significant step forward for UK clinical trials [that] come at a crucial time for industry clinical research in the UK.”

The organisation said it particularly welcomed new guidance to help researchers involve people with lived experience in clinical trials and recruit a diverse cohort of participants. In the document, the MHRA says it will provide clear guidance on diversity in trials without imposing targets or arbitrary quotas.

“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,” said ABPI's chief executive, Richard Torbett.