UK Clinical Trial Reforms Show Early Success — 82% of Studies Hit Recruitment Targets

Reforms to the UK clinical trial framework that came into force on 28 April 2026 are beginning to deliver measurable improvements: in July 2026, 82% of studies met their recruitment targets, exceeding the MHRA’s 80% benchmark.

Key Reforms and Goals

The UK Government has set new performance objectives for the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) as part of its 10-year NHS plan. The package — the first major overhaul for the sector in around 20 years — includes:

• Faster assessment for first-in-human trials to reduce delays for early-phase research.
• Notifiable trials, a new fast-track pathway for lower-risk studies to start sooner.
• Quicker approval routes for protocol modifications, while maintaining high safety standards.
• An overall target to reduce clinical trial set-up times to 150 days.

Early Performance Metrics

Early data indicate progress across several operational measures:

• Recruitment On Time: Delivery of recruitment to schedule was 82% in July 2026, above the MHRA’s 80% target; this rate has remained broadly stable month-to-month since August 2025.
• Median Time To First Participant: Between April and September 2025 the median time from application to first participant recruited was 122 days.
• Set-Up Status Within 150 Days: Of nine studies submitted to the MHRA in January 2026, 100% had a known set-up status within 150 days, up from 62% in April 2025. November 2025 was the only other month to reach 100% in the April 2025–January 2026 window. The MHRA’s target for this metric is 95%.
• Year-on-Year Improvement: For April–September, 73% of studies had a known set-up status within 150 days in 2025 versus 45% in 2024.
• Combined Review Approvals: Since May 2025, at least 96% of studies each month were approved within 60 days following a combined review, with 100% approval in September 2025, November 2025 and March 2026 — meeting the MHRA’s 99% aspiration.

Participation And Shortfalls

Participant recruitment totalled 89,102 people in 2025, down from 100,287 in 2024. The highest enrolment years remain 2020 and 2021 due largely to large Covid-19 vaccine trials.

Not all operational targets are yet being met: in January 2026, only 56% of studies opened to recruitment within 60 days of HRA approval (target 90%), and 61% recruited their first participant within 30 days (MHRA target 90%). These gaps highlight areas needing continued focus.

Industry Reaction And Context

“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.” — Peter Rudd-Clarke, partner, Osborne Clarke (April 2026)

The reforms follow a 2023 report by Lord James O'Shaughnessy that found a 44% reduction in commercial clinical trial starts between 2018 and 2023, with the UK falling from fourth to tenth in global trial initiation rankings. Early 2025–2026 data suggest the reforms are helping to reverse some delays, but policymakers and industry leaders warn that regulation is only one piece of restoring competitiveness.

Outlook: The initial data are encouraging: recruitment performance and approval timelines have improved, but work remains to meet targets for opening sites and recruiting the first participant promptly. Continued monitoring, coupled with broader incentives for investment, will determine whether these reforms translate into sustained growth in UK clinical research.