The UK clinical trials landscape is showing renewed strength, with the Medicines and Healthcare products Regulatory Agency (MHRA) declaring the country has reestablished itself as a global leader in the field.
The statement follows the publication of a comprehensive paper by the MHRA and the University of Liverpool in the British Journal of Clinical Pharmacology.
This marks the first detailed analysis conducted by a UK regulator assessing national clinical trial submissions.
UK Clinical Trials Submissions: Key Trends and Findings
Between February 2019 and October 2023, the MHRA’s Clinical Trials Unit (CTU) received 4,616 initial submissions. Submissions peaked in 2020, with the lowest volume in 2023. Phase III trials dominated the landscape, and nearly 85% of all trials were led by commercial sponsors.
The research showed balanced gender representation in most studies, although male-only trials were twice as common as those exclusively involving women. Elderly participants appeared more frequently than younger adults, while teenagers were the most studied pediatric group. Pregnant and breastfeeding women were significantly underrepresented, mostly participating in Phase III and IV trials.
Trials with healthy volunteers accounted for less than 20% of submissions and were primarily Phase I studies.
Cancer Dominates While Other Conditions Are Underrepresented
Cancer was the most common research focus, representing nearly one-third of all clinical trials in the UK. However, researchers noted a critical imbalance: heart disease, the leading global cause of death, represented only 5.2% of trials. Chronic pain, respiratory conditions, and mental health disorders also received disproportionately low research attention despite their heavy burden on public health.
Supporting Innovation and Reform in the UK Clinical Trials Sector
Despite a previous report by Lord James O’Shaughnessy highlighting a 44% drop in commercial trial activity between 2017 and 2022, recent data points to renewed investment by pharmaceutical and biotech firms in the UK.
The MHRA says the findings are shaping a modernized, more adaptive regulatory framework that aligns with O’Shaughnessy’s recommendations. These reforms aim to enhance efficiency, diversity, and accessibility in the clinical trial sector.
MHRA CEO Lawrence Tallon noted that approval times for combined reviews are now down to 60 days or less, positioning the UK as a top destination for research and innovation. “These changes not only benefit patients today but are laying the groundwork to accelerate innovation and deliver life-changing treatments to patients faster,” he said.
Looking Ahead: Investment and Innovation in UK Clinical Research
The MHRA will continue to use this data to develop more inclusive and forward-looking regulations, improve research into underrepresented conditions, and foster greater diversity in trial participation.
The effort coincides with a major financial boost, as the UK Government recently announced £600 million ($764 million) in funding to launch a new national health data service that will support researchers and accelerate discovery across the country.
