The Medicines and Healthcare products Regulatory Agency has said that two new AI tools have made it possible to cut the time needed to approve clinical trials of new treatments
As reported by UK Authority, trials of the new AI tools have shown they can cut clinical trial approval times from an average of 91 days to just 41.
Findings published in the British Journal of Clinical Pharmacology (BJCP) reveal that 99% of applications reviewed through the MHRA’s Combined Review process meet statutory deadlines, with most completed well ahead of schedule.
The first tool, the Good Manufacturing Practice (GMP) Compliance Checker, automatically verifies manufacturing documents in seconds rather than hours, freeing experts to focus on complex safety assessments.
Meanwhile, the Knowledge Hub helps assessors identify recurring issues from previous applications, enabling them to provide clearer, higher-quality advice to trial sponsors early on, helping well-designed studies get underway faster.
Meanwhile, digital dashboards provide real time visibility of all active applications in the UK’s trial portfolio, helping the MHRA track performance and deliver more predictable timelines.
MHRA chief executive Lawrence Tallon said: “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.”
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