The UK’s clinical research landscape has been mapped in unprecedented detail following the first-ever analysis of clinical trial applications submitted to the Medicines and Healthcare products Regulatory Agency (MHRA). This landmark report, conducted in collaboration with the University of Liverpool and published in the British Journal of Clinical Pharmacology, offers a comprehensive baseline assessment, highlighting the UK’s strengths while pinpointing key opportunities to accelerate medical breakthroughs for patients.
The analysis scrutinised all 4,616 clinical trial applications submitted between 2019 and 2023, providing the most detailed picture yet of UK clinical research activity involving medicines.
Key Findings: A Snapshot of the UK Trial Landscape
The report confirms the UK’s position as a significant hub for innovative medical research but also identifies areas needing attention:
- Pioneering Research Hub: The UK excels in early-stage research, with one in every eight trials analysed being a first-in-human study.
- Strong Commercial Investment: Industry sponsorship is robust, accounting for 85% of trials, indicating strong commercial confidence in the UK environment. Non-commercial sponsors like universities, hospitals, and charities make up the remaining 15%.
- Concentration in Oncology: Cancer research dominates, representing nearly one-third of all studies submitted.
- Underrepresentation of Major Diseases: Despite their significant public health impact, trials for other major conditions lag behind. Heart disease, the world’s leading cause of death, accounted for only 5.2% of trials. Research into chronic pain, respiratory conditions, and mental health disorders was also notably less common.
- Participant Diversity Gaps:
- While most trials (90%) included both sexes, male-only studies (6.1%) were nearly twice as prevalent as female-only studies (3.7%).
- Inclusion of pregnant and breastfeeding women was very low (1.1% and 0.6% respectively), potentially limiting evidence for treatments in these groups.
- Advanced Therapies Potential: Cutting-edge treatments like gene and cell therapies, while a growing area, constituted only 3.4% of trials analysed, despite their potential to revolutionise care for patients with limited options.
Identifying Opportunities for Growth and Inclusion
This detailed analysis serves as more than just a status report; it’s a roadmap highlighting clear opportunities to enhance the UK’s clinical research ecosystem:
- Broadening Research Focus: Encouraging and supporting trials in underrepresented therapeutic areas like cardiovascular disease, chronic pain, and mental health.
- Enhancing Diversity: Actively working to improve the representation of diverse patient groups, including women (especially pregnant and breastfeeding individuals) and potentially other underrepresented demographics, to ensure treatments are safe and effective for everyone.
- Boosting Advanced Therapies: Fostering growth in trials for innovative cell and gene therapies.
- Attracting Investment: Leveraging the UK’s strengths to attract further global investment in the face of a growing global clinical trials market (projected to exceed £80 billion by 2032).
MHRA’s Strategic Response: Towards Faster, Fairer Trials
The MHRA is proactively using these insights to shape policy and regulation, aiming to make UK clinical trials “faster, fairer, and more inclusive.” Key actions include:
- New Regulatory Framework: Implementing new clinical trial regulations, recently signed into law (April 2025) with a 12-month implementation period. These aim to create a more efficient, streamlined, flexible, and risk-proportionate system, reducing bureaucracy, especially for lower-risk trials. This builds on improvements already made, such as the Combined Review process achieving approval times of 60 days or less.
- Collaboration: Working closely with patients, the NHS, industry, academia, and the Health Research Authority (HRA) to implement changes, including developing joint HRA/MHRA guidance on improving trial diversity.
- Targeted Support: Utilising pathways like the Innovative Licensing and Access Pathway (ILAP) and supporting advanced therapies through initiatives like the Centres of Excellence for Regulatory Science and Innovation (CERSIs).
Professor Andrea Manfrin, lead author and MHRA Deputy Director, Clinical Investigations and Trials, stated: “Clinical trials are the backbone of medical progress… This analysis shows clearly where the UK is leading – and where we need to work with our stakeholders to go further… Better trials mean better, more effective treatments, reaching NHS patients as quickly and as safely as possible.”
Future Outlook: Strengthening UK Life Sciences
This first-of-its-kind analysis provides a crucial baseline for measuring future progress. By identifying both strengths and areas for development, the MHRA and its partners can strategically enhance the UK’s clinical trial environment. Supported by government initiatives and investment, including recent funding announcements to “turbocharge” medical research, the goal is to solidify the UK’s position as a world leader in life sciences, accelerate the delivery of innovative treatments to patients, and boost economic growth.
