Data from MHRA shows clinical trial applications received rose by 9% between January and November 2025, compared with the same period in 2024. Growth was strongest in early and innovative research, where speed and expert regulatory support can make or break decisions on where companies invest.
For example, trials involving healthy volunteers increased by 16%, alongside rises in trials testing treatments in people for the first time (5%), and those being run in the UK for the first time (7%), a sign of growing international confidence in the UK as a place to launch new research.
More broadly, patient participation in clinical research is now higher than before the pandemic. Across England, more than 450,000 people took part in studies last year, underlining the role trials play in giving patients access to new treatments.
In addition, the number of MHRA scientific advice meetings provided on clinical trials rose by 75% over that period, as developers seek to design trials right first time and avoid costly delays later on.
New clinical trial regulations are due to take effect from April, under which around one in five studies are expected to move to a fast-track notification route, which will enable lower-risk trials to start sooner, while maintaining high safety standards and freeing up experts to focus on complex and early-phase studies. The MHRA will also introduce a 14-day assessment route for phase 1 trials, adopting an innovative stepwise approach, restoring a rapid pathway for the earliest testing of new medicines in people – a key draw for global developers deciding where to base their research.
The new framework will also support clearer, more agile routes to support innovation. This includes making better use of early safety data from overseas studies that meet UK standards, and new MHRA capability to assess computer model simulations to help predict how new medicines may behave before they are tested in patients.
Health innovation minister, Dr Zubir Ahmed, said: ‘This Government is laser-focused on accelerating clinical trial set-up times and cementing our position as global leaders. 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.
'Our Plan for Change is working to drive global investment into life sciences and our economy, improve health outcomes and accelerate the development of medicines and therapies of the future.'
MHRA chief executive, Lawrence Tallon, added: ‘Clinical trial sponsors are clear about what they need: speed, clarity and flexibility. We've made practical improvements that are helping trials move through the system more smoothly. The biggest shift is still to come. New rules will make it simpler to start lower-risk studies, strengthen support for early-stage research and embrace modern approaches, including adaptive trial designs and computer model simulations, while maintaining patient safety.
'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.'
