AI platforms slash clinical trial approval times in half

The time it takes to approve UK clinical trials has decreased by 55% – from 91 days to 41 days – following ‘major reforms’ and new digital platforms at the Medicines and Healthcare products Regulatory Agency (MHRA), new research confirms.

According to findings published this week in the British Journal of Clinical Pharmacology (BJCP), 99% of clinical trial applications were reviewed within statutory timelines, and more were completed well ahead of target.

The study is the first comprehensive review of the MHRA’s new way of reviewing trials based on their level of risk, introduced in August 2023.

This brings new treatments to patients several weeks sooner than before.

A fast-track route also allows some lower-risk studies to be approved in 14 days. For example, a haemophilia A trial was able to begin several weeks earlier than expected, giving patients faster access to life-changing therapy.

AI is now being introduced to further support assessors by scanning thousands of pages of complex data. Final decisions still rest with experienced assessors to ensure patient safety.

Two new MHRA AI tools have been particularly effective. The Knowledge Hub helps assessors spot common issues seen in past applications, helping well-designed trials to get underway sooner; the Good Manufacturing Practice (GMP) Compliance Checker verifies manufacturing documents in seconds, freeing up experts to focus on complex safety assessments.

In addition, digital dashboards help the MHRA track performance by showing proving real-time visibility of all active clinical trial applications in the UK.

Health Minister Stephen Kinnock said: ‘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.

‘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.’

The BJCP study reviewed more than 4,600 clinical trial initial applications and amendments in the first year of the MHRA’s risk-proportionate approach. It was conducted by the MHRA in collaboration with the University of Liverpool.

The MHRA deputy director for clinical investigations and trials, and lead author of the study, Professor Andrea Manfrin: ‘Digital innovation and risk-proportionate oversight mean lower-risk studies can move ahead without unnecessary delay, while higher-risk trials still receive the detailed expert review they require.

‘Researchers can know they’re in good hands, with a regulator ready to support complex, next-generation therapies – and patients can be confident that safety always comes first.’

MHRA chief executive Lawrence Tallon said the reforms put patients first by speeding up access to innovative treatments without compromising the highest safety standards.

He also said the MHRA was increasing the efficiency and attractiveness of the UK’s clinical trial ecosystem and strengthening the country’s reputation for cutting-edge research.

These reforms contribute to the Prime Minister’s pledge to cut clinical trial set-up times to 150 days.

All UK clinical trials will be required to publicly register and publish their results, including easy-to-read summaries for participants, as of April 2026 when new legislation comes into force. This will further embed the clinical trial digital reforms.

The legislation will also give sponsors more flexibility, by extending the deadline to respond to regulator feedback from 14 to 60 days – helping align with international trial timelines.

This follows fears that the UK will face difficulty running clinical trials, given the impasse between the ABPI and the Government over NHS medicine pricing.

Last month, another new tool was developed to help identify problematic randomised controlled trials (RCTs), including those suspected of being fraudulent or containing methodological flaws.

The tool, known as Inspect-SR, was developed by more than 150 researchers, led by Dr Jack Wilkinson from the University of Manchester.