AI halves clinical trial approval times

A study by the British Journal of Clinical Pharmacology (BJCP) has shown that by using artificial intelligence (AI), clinical trial assessors have been able to more than halve the time it takes to approve new therapies.

The study looked at how reforms by the Medicines and Healthcare Products Regulatory Agency (MHRA), including the use of AI and digital platforms, have affected the approval times for trials.

The MHRA is now reviewing trials based on their level of risk, allowing a fast-track route for lower-risk studies, which means trials can be approved in as little as two weeks. Overall, the average time for approval has reduced from 91 to 41 days.

Assessors can use AI tools to scan the trial data and flag potential issues, which can then be reviewed by a human. The MHRA is also introducing two further AI tools – the Knowledge Hub and the Good Manufacturing Practice Compliance Checker.

The hub helps spot common issues in applications, so assessors can offer better and clearer advice, and the compliance checker verifies manufacturing documents in seconds.

Health minister Stephen Kinnock said the use of AI in clinical trials is part of the government’s 10-year health plan and will improve treatments for patients.

“We are halving approval times and streamlining processes, so NHS patients are at the front of the queue and receiving life-changing treatments faster than ever before,” he said.

“As we shift from analogue to digital, we are harnessing AI, alongside cutting red tape and reforming bureaucratic processes, so patients can receive medicines in just 41 days instead of 91. We are getting on with modernising our NHS for patients and making it fit for the future – because when someone is fighting for their health, every day matters.”

As part of the government’s 10-year plan for the NHS, prime minister Keir Starmer has vowed to “turbocharge” clinical research and cut the time it takes to set up a clinical trial to 150 days.

In April 2026, the government will introduce new legislation that means all clinical trials will have to publicly register and publish their results. People will also soon be able to sign up to take part in clinical trials on the NHS App.

MHRA CEO Lawrence Tallon said the reforms are helping to put patients first, while also maintaining the “highest safety standards”.

“They also give researchers and global companies the certainty they need to plan and invest here in the UK,” he added.

“By more than halving approval times through digital tools with proportionate oversight that prioritises patient safety, we are increasing the efficiency and attractiveness of the UK’s clinical trial ecosystem and reinforcing our global reputation as a leading destination for cutting-edge research.”

The BJCP study reviewed more than 4,600 clinical trial applications, and found that with the use of digital tools, nearly all applications were completed within the statutory 30-day timeframe.

The study, which is the first national study of the country’s clinical trials, also found opportunities to improve diversity, address under-represented conditions and attract investment internationally.