20-05-2025
UK clinical trial sector progress ‘remarkable', says former health minister
The progress the UK has made as a global contributor to clinical trials is 'remarkable', says Lord James O'Shaughnessy, former health minister and author of the landmark report into the domestic commercial clinical trials sector.
Two years on from the publication of his review, and on Clinical Trials Day (20 May), O'Shaughnessy said that the Medicines and Healthcare products Regulatory Agency (MHRA) is once again taking a global lead.
'The progress the MHRA has made in the two years since I published my review has been remarkable. Despite its global reputation for excellence, by 2023, trial approval set-up times had slipped badly,' O'Shaughnessy said.
'The MHRA is now delivering consistently good approval times while introducing further reforms to add speed and flexibility to the process. With a clear mandate from the prime minister to reduce trial set-up times to 150 days, which would be genuinely world-leading, the MHRA is once again taking a global lead.'
Lord O'Shaughnessy became a well-known name in the clinical trial sector after his review was published in May 2023. The review made 27 recommendations where action should be taken by the government and delivery partners, including the MHRA, to address key challenges and transform the UK's commercial clinical trials environment.
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.
Tallon 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.
"But we want to go further. Last month, we began implementing the most significant update to UK clinical trials regulation in over two decades. These reforms will address the research sector's need for a more risk-proportionate regulatory framework for clinical trials and will help get cutting-edge new treatments to the NHS as quickly as possible.'
Last month, the MHRA placed the UK as a global leader in clinical trials once again following a collaborative report with the University of Liverpool, which was published in the British Journal of Clinical Pharmacology.
On top of April's regulation, which was first announced in December 2024, the MHRA is launching a six-week consultation on the use of real-world data (RWD) for external control arms of clinical trials, which has the potential to help accelerate the approval of treatments, especially when randomised controlled trials may not be ethical or feasible.
The new guidance is for those planning a clinical trial that may include an RWD external control arm to support a regulatory decision on a medical product.
In April 2025, the UK Government announced it would invest £600m ($764m) into a new Health Data Research Service to support researchers. The investment will provide researchers with a secure access point to national datasets to be used in research.
The regulation implemented last month should reduce unnecessary administrative burdens on trial sponsors without compromising patient safety. They are also designed to protect trial participants, facilitate the development of new medicines, remove obstacles to innovation, and ensure that legislation enables trial sponsors to work across countries.
The legislation is part of a broader overhaul by the MHRA, supported by health system partners including the Health Research Authority (HRA), academia and researchers.
The new regulations will be accompanied by guidance from the MHRA and HRA to embed meaningful public involvement in clinical trials and increase participant diversity. The regulatory bodies hope this will demonstrate the UK's potential as a research base that can improve care and minimise health inequalities.
The MHRA has also improved its processing of clinical trial applications, with 100% of clinical trials and investigations applications having been handled within statutory timescales since September 2023.
"UK clinical trial sector progress 'remarkable', says former health minister" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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