Clinical trial setup times fall sharply in UK

Reforms to the regulatory framework for clinical research in the UK are starting to deliver, with delivery times slashed by 35%, according to new government figures.

According to the Department of Health and Social Care (DHSC) and the Office of Life Sciences (OLS), the average setup time for commercial clinical trials in the UK dropped to 100 days in the first quarter – down from 153 days in the previous year - which exceeded the target of keeping set-up times under 150 days.

Meanwhile, 100% (24 out of 24) commercial trials recorded during that period were established within the 150-day window, beating the 95% target laid out in the Life Sciences Sector plan published last year.

That means the original target of getting UK clinical trials up and running within an average of 150 days by March 2026 – from an earlier level of around 250 days – has been comfortably surpassed, fulfilling a key metric designed to make the UK a faster, more predictable and easier place for life sciences companies to run high-quality studies.

Trials that have benefited from accelerated delivery times include Quell Therapeutics' phase 1/2 CHILL study of one-shot cell therapy QEL-005 for serious inflammatory disorders and Moderna's Nova 301 study of norovirus vaccine candidate mRNA-1403.

"For patients and their families, a clinical trial can offer hope of a treatment that once seemed unimaginable," commented Health Innovation Minister James Frith. "That's why meeting this target is so important. It means more patients will get the cutting-edge care they need sooner."

Among the reforms introduced to try to reverse a steep decline in commercial clinical trials in the UK in recent years were combined ethical and regulatory reviews, fast-track and notification routes for low-risk studies, a two-week assessment pathway for first-in-human studies, and greater use of digital and AI tools to speed up application and compliance checking.

The new data show that 100% of studies receiving combined regulatory and ethical approvals in September 2026 did so within 60 days, according to the DHSC.

That said, long set-up times are just one factor that has contributed to the UK slipping behind some other countries as a hub for clinical research, and others – like low patient recruitment rates and rising costs – are other important metrics that need to improve.

Steve Bates, OLS executive chair and formerly head of the BioIndustry Association (BIA), said the new data reveals "significant progress" in reducing trial set-up times, but cautioned: "We must now build on this."

Noting that global competition for life sciences investment is now intense, he said that "sustained delivery will be essential if the UK is to increase the number of patients participating in commercial trials and ensure that people can benefit from research regardless of where they live."