STORY
Marking International Clinical Trials Day, the Medicines and Healthcare products Regulatory Agency (MHRA) today hailed “remarkable” progress under its new risk-proportionate clinical trial regulations and launched a six-week public consultation on using real-world data to support future trial designs. Since introducing the most significant overhaul of UK trial rules in over 20 years, the MHRA reports that 100% of clinical trial applications have met statutory approval timelines, with the combined MHRA–Health Research Authority review now taking an average of 40 days, down from 150. Chief Executive Lawrence Tallon emphasised that one in eight trials in the UK test treatments in humans for the first time, and that these reforms will help bring cutting-edge therapies to patients more swiftly.
Lord O’Shaughnessy, author of the landmark 2023 review into the UK’s commercial trial landscape, praised the agency’s delivery on his recommendations, saying that the MHRA is once again taking a global lead with world-class approval times and fresh reforms to boost speed and flexibility. Professor Sir Martin Landray, CEO of Protas, added that this “regulatory enlightenment” is vital if the UK is to remain at the vanguard of innovative trial methodologies against life-threatening diseases.