Clinical trial activity rises as MHRA prepares to fast-track studies

Clinical trial activity in the UK is increasing, with applications up 9% last year, as the Medicines and Healthcare products Regulatory Agency (MHRA) prepares to introduce reforms to boost it even further.

The MHRA said that clinical trial applications rose by 9% between January and November 2025 compared with the same period in 2024.

The biggest growth was in early-stage and innovative research with applications involving healthy volunteers, increasing by 16%.

Related Article: Payment percentage for statutory branded medicines scheme drops to 16.5%

Developers also appear to be approaching the MHRA earlier in the process, with scientific advice meetings up by 75% as companies sought to design studies more efficiently and avoid delays later on.

New regulations coming into effect in April will create a fast-track route for lower-risk studies, allowing some trials to start sooner. Around one in five applications is expected to qualify.

MHRA chief executive Lawrence Tallon believes the new rules will simplify processes and support innovation without compromising safety.

'We've made practical improvements that are helping trials move through the system more smoothly,' he said.

'Together, these reforms will help high-quality trials start sooner, giving patients earlier access to new medicines and making the UK a more competitive place to develop them.'

Related Article: Research review: a look at the latest clinical papers

More than 450,000 people took part in clinical research in England in 2025 – a higher number than before the pandemic – and the government wants to cut the time from trial application to first participant to 150 days.

Health innovation minister Dr Zubir Ahmed said: 'These improvements mean we are making it even easier for companies to bring clinical trials to the UK, offering a single point of support, faster processes, and a more predictable pathway to launch studies.'

The new framework is also designed to make it easier to use data from overseas studies that meet UK standards, and to assess computer modelling that predicts how new medicines may work.

Professor Lucy Chappell, chief scientific adviser at the Department of Health and Social Care, said: 'Accelerating the set-up of clinical trials is critical to keeping the UK at the forefront of research on the global stage.

Related Article: MenB vaccination programme to be rolled out in pharmacies

'When trials can start more quickly and predictably, sponsors are more confident in investing in the UK, meaning our R&D landscape can thrive and we can ensure better outcomes for patients.'

Earlier this month, cardiovascular medicine expert Professor Jacob George, began his role as the first chief medical and scientific officer (CMSO) at MHRA.