AI tech ‘halves’ time taken to approve UK clinical trials

The time taken to approve clinical trials in the UK has dropped from an average of 91 days to just 41 days thanks to AI and other technology platforms, according to new findings published in the British Journal of Clinical Pharmacology (BJCP).

Shorter waiting times follow “major reforms” backed by new digital platforms and AI technology at the Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA says that the new technology has allowed patients to safely access promising new treatments such as cancer therapies and rare disease studies several weeks sooner than before.

The reforms also support wider government efforts to modernise the UK’s research landscape through the 10 Year Health Plan, which aims to streamline trial setup by slashing red tape, simplifying paperwork and introducing a national standardised contract to remove months of delay.

The BJCP analysis, which was conducted by the MHRA in collaboration with the University of Liverpool, reviewed more than 4,600 clinical trials, initial applications and amendments in the first year of the MHRA’s risk-proportionate approach, launched with patient input in August 2023.

The research found that some 99 per cent of initial applications were completed within the statutory 30-day timeframe, while 99.9 per cent of amendments were completed within 35 days, with many decisions delivered well ahead of target.

AI has helped to support clinical trial assessors, scanning thousands of pages of data to flag potential issues for human review.

The MHRA said that several tools have sped up the process, including the Knowledge Hub, which helps assessors spot common issues seen in past applications so they can give trial sponsors clearer, higher-quality advice from the start.

The Good Manufacturing Practice (GMP) Compliance Checker verifies manufacturing documents in seconds instead of hours which frees up experts to focus on complex safety assessments.

The MHRA added that digital dashboards provide real-time visibility of all active applications in the UK’s trial portfolio, helping it track performance and deliver more predictable timelines.

AI is now being introduced to further support assessors, helping review complex data and improve consistency, while final decisions continue to rest with experienced assessors to ensure patient safety.

“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,” said health minister Stephen Kinnock. “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.”

New legislation coming into force in April 2026 is expected to strengthen the healthcare reforms further as all UK clinical trials will be required to publicly register and publish their results, including easy-to-read summaries for participants.

This means for the first time patients will be able to see, in plain language, what a study found, which the government said could help strengthen trust in science and encourage more people to take part in research.