The UK is approving clinical trials twice as fast using AI
The time it takes to approve clinical trials in the UK has been cut by more than half – from an average of 91 days to just 41 days – following major reforms backed by new digital platforms at the Medicines and Healthcare products Regulatory Agency (MHRA), new research confirms.
Findings published this week (6 October) in the British Journal of Clinical Pharmacology (BJCP), show the reforms are delivering consistently strong results, with 99 per cent of applications reviewed within statutory timelines, and most 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 2023, showing how it speeds up review timelines while protecting patient safety.
A fast-track route allows some lower-risk studies to be approved in just 14 days.
For example, under the 14-day notification scheme, a haemophilia A trial was able to begin several weeks earlier than expected, giving patients with this serious bleeding disorder faster access to potentially life-changing therapy.
Building on this, artificial intelligence (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.
The reforms also support wider Government efforts to modernise the UK’s research landscape through the 10 Year Health Plan – streamlining trial setup by slashing red tape, simplifying paperwork and introducing a national standardised contract to remove months of delay.
Millions of people will also be able to search for and sign up to lifechanging clinical trials, via the NIHR Be Part of Research service on the NHS App, allowing patients to browse and find the trials best suited to their interests and needs.
“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.”
