The UK is ramping up efforts to become a global first choice for clinical trials, as new figures show a sharp rise in activity in 2025, and changes coming this year – including a fast-track route – designed to help companies get studies up and running more quickly.  

Data from the Medicines and Healthcare products Regulatory Agency (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%), interpreted as a sign of growing international confidence in the UK as a place to launch new research.  

Companies are also coming to regulators earlier for help. 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. 

Dr Janet Valentine, Director of Innovation and Research Policy at the ABPI, commented: “The rise in clinical trial applications reported by the MHRA is an encouraging sign and reinforces the growth in industry-led clinical trial initiations in the UK during 2024, as highlighted in the ABPI’s latest annual clinical trials report. 

“Speed and predictability in regulatory approvals are critical to setting up clinical trials and will be essential to meeting the government’s ambition of a 150-day set-up. These improvements must be sustained, so the UK can consistently deliver rapid trial set-up and timely patient recruitment.” 

A 14-day assessment for Phase I trials

New clinical trial regulations are due to take effect from April. Under the new rules, around one in five studies are expected to move onto a fast-track notification route. The MHRA will also introduce a 14-day assessment route for Phase I trials.  

The new framework will make better use of early safety data from overseas studies that meet UK standards, and new MHRA capability to assess computer model simulations, such as in silico trials. 

The reforms support the government’s ambition to cut the time from trial application to first participant to 150 days. 

MHRA Chief Executive Lawrence Tallon said: “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.” 

Diana Turner, Deputy Editor, DDW