UK clinical trial sector progress ‘remarkable’, says former health minister
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UK clinical trial sector progress ‘remarkable’, says former health minister
On Clinical Trials Day 2025, the MHRA has announced further plans to support the UK’s clinical trial sector by improving access to real-world data. Lord James O’Shaughnessy said that the Medicines and Healthcare products Regulatory Agency (MHRA) is once again taking a global lead. The MHRA chief executive Lawrence Tallon also reflected on the new regulations by the agency, which help to create patient-centric trials and provide a faster and more streamlined approval system. He said: “The UK is already a research powerhouse driven by innovation, with one in eight trials in the UK testing treatments in humans for the first time.” The UK Government announced it would invest $764m into a new Health Data Research Service to support researchers in April 2025. The investment will provide researchers with a secure access point to national datasets to be used in research. The new regulations will be accompanied by guidance from theMHRA and HRA to embed meaningful public involvement in clinical trials.
Source: Clinicaltrialsarena.com | Read full article
MHRA Launches Data Consultation on Clinical Trials Day
New regulations represent the most significant update to the UK clinical trials landscape in 20 years. They are designed to put participants firmly at the centre of how trials are run. They also support faster, more streamlined approvals, making it easier to test new treatments in the UK. Launch of consultation on the use of real-world data for external control arms of clinical trials, which has the potential to help accelerate the approval of treatments, especially in cases when randomised controlled trials may not be ethical or feasible. New regulations will take full effect from April 2026, following the 12-month implementation period. The MHRA and Health Research Authority (HRA) will be producing updated guidance to ensure these substantial reforms are phased in effectively. One in eight trials in UK testing treatments in humans for the first time. Trial approval set up times now at 60 days or less for all trials. Average time for Combined Review determination (including questions raised) of 40 days in March 2025.
Source: Miragenews.com | Read full article
New real-world data guidance could accelerate drug approvals
New real-world data guidance could accelerate drug approvals in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) has declared there has been ‘major progress’ in the delivery of regulatory framework to make UK clinical trials more efficient and flexible. The MHRA has launched a new six-week consultation on the use of real- world data for external control arms of clinical trials. The organisation stated that this could speed up authorisation of medicines. They added that the new guidance is relevant for those planning clinical trials which may include a real-World data external control arm, of which the trial is intended to support.
Source: Europeanpharmaceuticalreview.com | Read full article
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Source: https://www.clinicaltrialsarena.com/news/uk-clinical-trials-sector-remarkable-progress-former-health-minister/