First-ever MHRA analysis of UK clinical trial applications finds new opportunities to drive medical breakthroughs for patients
Source: gov.uk (2025-04-10)

New analysis of the current clinical trial landscape in the UK shows clear opportunities to shape the future of medical research and patient care.

The first-ever analysis of the UK clinical trial landscape by the Medicines and Healthcare products Regulatory Agency (MHRA) and the University of Liverpool reveals the UK is a global leader in clinical research – and sets out key opportunities to deliver even more life-changing treatments for patients.

Published today in the British Journal of Clinical Pharmacology, the report offers the most detailed picture yet of the UK’s clinical trials landscape. It finds strong innovation – but also a concentration of research in certain disease areas, and opportunities for increased representation of certain patient groups.

A roadmap for stronger, more inclusive research

The MHRA is using the insights to build upon the country’s world-leading clinical research and deliver its new clinical trials regulations to create a more efficient, streamlined and adaptable regulatory framework. Working in partnership with patients, the NHS, industry and academia, the MHRA will support increased research into underrepresented conditions, improve diversity in trial participation, and attract further global investment in innovation.

Professor Andrea Manfrin, lead author of the study and MHRA Deputy Director, Clinical Investigations and Trials, said:

“Clinical trials are the backbone of medical progress, essential for developing new medicines and advancing our understanding of diseases. This analysis shows clearly where the UK is leading – and where we need to work with our stakeholders to go further. By working together with patients, the NHS, industry, and researchers across the life sciences ecosystem to identify and maximise these opportunities, we can ensure clinical trials are faster, fairer, and more inclusive. Better trials mean better, more effective treatments, reaching NHS patients as quickly and as safely as possible.”

Professor Sir Munir Pirmohamed, co-author of the study at the University of Liverpool, said:

“The analysis from the MHRA clinical trials database shows the richness of UK clinical trial activity involving medicines. Importantly it also provides a baseline which can be used to increase future UK clinical trial activity, which is important for improving both patient outcomes and economic investment.”

With the global clinical trials market expected to nearly double to over £80 billion by 2032, insights from the analysis will help shape policies that can bring innovative, new medicines to patients, attract investment, accelerate medical innovation, and expand trial access for UK patients.

Key findings from the MHRA and University of Liverpool’s analysis of all 4,616 clinical trials submitted between 2019 and 2023:
- The UK is a hub for pioneering research, with one in eight trials testing treatments in humans for the first time. There is strong commercial investment in UK trials, with 85% industry sponsored. A smaller share (15%) comes from universities, hospitals, and charities.
- Cancer trials dominate, making up nearly a third of all studies, but other major diseases lag behind. Heart disease – the world’s biggest killer – receives just 5.2% of research focus. Trials for conditions such as chronic pain, respiratory conditions and mental health disorders were among the least common, despite their major impact on public health.
- Both sexes were included in most trials (90%), however male-only trials (6.1%) were nearly twice as common as female-only studies (3.7%). Pregnant and breastfeeding women were represented in 1.1% and 0.6% of trials, respectively, which could impact treatment suitability for these groups.
- Cutting-edge treatments, such as gene and cell therapies, represent a growing clinical area but make up only 3.4% of trials, despite their potential to transform care for patients with limited treatment options.
Partnership working to strengthen UK clinical research

The report sets a baseline to track progress and inform future funding, policy and regulation. The MHRA is already working with partners across the life sciences sector to increase research and streamline approvals in areas of unmet need through the Innovative Licensing and Access Pathway (ILAP); improve diversity in trial participation through the development of joint guidance with the Health Research Authority (HRA) so trials reflect the populations they aim to serve; and support more advanced therapy trials through collaboration with researchers via the Centres of Excellence for Regulatory Science and Innovation (CERSIs).

These initiatives form part of wider clinical trials reform, including new legislation we are committed to implementing that will streamline how clinical trials are run in the UK. Backed by the MHRA and healthcare system partners, the changes aim to protect patient safety, boost global investment, and cut unnecessary red tape – helping bring new treatments to patients faster.

As the government pushes forward the development of the Life Sciences Sector Plan and the 10 Year Health Plan, these findings come at a crucial time. They can be used to shape policies that ensure clinical trials deliver maximum benefit for patients, the NHS and the wider economy.

Health Minister Karin Smyth said:

“The government is determined to make Britain a world leader in life sciences, developing groundbreaking treatments focused on the conditions that matter most to patients.

“As part of our Plan for Change, we’re laying the foundations for a modern, resilient health system that delivers, which is why the Prime Minister announced £520 million investment this week to turbocharge medical research.

“By driving forward research and expanding access to clinical trials, we can ensure patients benefit from cutting-edge treatments quicker, while creating high-quality jobs and attracting global investment.

“Strengthening the trial environment will help ensure we have an NHS fit for the future – one that harnesses innovation to improve outcomes for patients.”

Science Minister Lord Vallance said:

“As home to a thriving life sciences sector and the NHS, the UK is uniquely placed to host the trials and research that are taking the fight to a host of devastating health conditions. But as this data shows, we can go further and move faster through targeted investment, and smart regulation.

“We are committed to doing precisely that – through this year’s record £13.9 billion funding for R&D in life sciences and beyond, as well as the efforts of our new Regulatory Innovation Office. We must make sure that trials of new medicines are available to everyone to take part.”

Lawrence Tallon, MHRA Chief Executive, said:

“This first-of-its-kind analysis builds on our important work to strengthen clinical research in the UK. We are committed to implementing a flexible and risk-proportionate regulatory approach for clinical trials, which accelerates patient access to potentially life-saving medicines without compromising safety.

“We’re making the UK one of the best places in the world to run clinical trials, with combined review approval times with the Health Research Authority now at 60 days or less for all trials. These changes not only benefit patients today but are laying the groundwork to accelerate innovation and deliver life-changing treatments to patients faster.”

Matt Westmore, Health Research Authority Chief Executive:

“Health and social care research should be done with, and for, everyone.

“We know that trials that involve a diverse group of participants help provide a better understanding of how effective a treatment is for different groups of people. In turn this helps us support efforts to address health inequalities.

“We are pleased to be working alongside the MHRA to develop new guidance designed to make it easier for researchers to ensure they are designing trials that are more representative of the people it is for and about.”

The MHRA will continue tracking progress and working with its partners to ensure the UK remains a world leader in medical research, keeping patient safety at the heart of clinical trials.

Notes to editors
- Publication: Andrea Manfrin et al. (2025) ‘Analysis of 4616 clinical trial initial submissions received by the MHRA between February 2019 and October 2023’ British Journal of Clinical Pharmacology. DOI: 10.1002/bcp.70061 (https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1002/bcp.70061).
- This analysis includes all 4,616 initial clinical trial submissions of investigational medicinal products (CTIMPs) received by the MHRA Clinical Trials Unit between February 2019 and October 2023. Other types of studies, such as non-CTIMPs, are not under the MHRA’s remit. For further information, please refer to the publication.
- Patients, the NHS and the Life Sciences sector set to benefit from new clinical trials framework being laid in parliament today - GOV.UK (https://www.gov.uk/government/news/patients-the-nhs-and-the-life-sciences-sector-set-to-benefit-from-new-clinical-trials-framework-being-laid-in-parliament-today)
- Commercial clinical trials in the UK: the Lord O’Shaughnessy review - GOV.UK (https://www.gov.uk/government/publications/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review)
- https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
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