08/20/2026  |  Abigail Beaney  |  Clinical Trials Arena

https://www.clinicaltrialsarena.com/news/reforms-to-uk-clinical-trial-sector-showing-signs-of-success/ 

The MHRA set out ambitious targets to have a 150-day set-up time, from application to recruitment, for clinical trials in the country.

Reforms to the UK clinical trial system seem to be working after 82% of studies were found to hit recruitment goals in July 2026.

In new targets for the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA), the UK Government hopes to reduce clinical trial set-up times to 150 days as part of its 10-year plan for the NHS.

MHRA and HRA reforms to clinical trials came into effect on 28 April, marking the first major change for the sector in20 years.

These developments, which were passed in parliament, include faster assessment of first-in-human trials and the introduction of notifiable trials, a fast-track route to allow lower-risk trials to start sooner, and modifications to be approved more quickly, while maintaining the highest safety standards.  

The data is already showing improvement in lots of metrics. The proportion of open studies is on track, and delivery of recruitment to time was 82% in July 2026, surpassing the 80% target from the MHRA. This figure has stayed relatively stable each month since August 2025.

Between April 2025 and September 2025, the median number of days from application to first participant recruited was 122.

Of the nine studies submitted to the MHRA in January 2026, 100% had a known set-up status within the 150-day target. This is compared to 62% in April 2025, showing significant improvement. The only other month between April 2025 and January 2026 to achieve a 100% set-up known rate is November 2025. The MHRA target for this is 95%.

When looking between April and September 2025, the percentage of studies with a known status of set up within 150 days was 73% compared to 45% for the same timepoint in 2024.

From May 2025, every month has seen at least 96% of studies approved within 60 days following a combined review. There were 100% successes in September 2025, November 2025 and March 2026, reaching the MHRA target of 99%.

In 2025, 89,102 participants were recruited into clinical trials in the UK. This is slightly lower than in 2024, where 100,287 participants were enrolled. Both 2020 and 2021 have the highest patient enrolment rates, but this data will be significantly boosted by the high enrolment in Covid-19 vaccine trials.

Other data shows that the proportion of studies opening to recruitment within 60 days of HRA approval was 56% in January 2026, lower than the target of 90%. The proportion of studies recruiting the first participant within 30 days was 61% in the same month, which is also lower than the MHRA target of 90%.

Speaking when these reforms came into place in April 2026, Peter Rudd-Clarke, partner at law firm Osborne Clarke, said: “The UK’s new clinical trials regime is a direct response to concerns that the UK has been losing ground as a destination for research, particularly post-Brexit. By streamlining approvals and reducing friction, the Government is trying to make the UK a more appealing location for pharma companies deciding where to run trials.

“The key question is whether that’s enough. While the reforms should help, competitiveness depends on more than regulation alone, and the industry will be watching closely to see the impact these reforms, and other related initiatives, have on making the UK a more attractive place to invest.”

This all follows a significant report published in 2023 by Lord James O’Shaughnessy, which discovered that the UK had a 44% reduction in commercial clinical trial initiation between 2018 and 2023, dropping from 4th to 10th as a global contributor.