New analysis sets stage for improved UK clinical trials

The Medicines and Healthcare products Regulatory Agency (MHRA) and the University of Liverpool have issued their first analysis of the clinical trial landscape in the UK. The report, published in the British Journal of Clinical Pharmacology demonstrated that currently, UK clinical trials exhibit “strong innovation”, as well as “a concentration of research in certain disease areas, and opportunities for increased representation of certain patient groups”.

Key findings for UK clinical trials

For clinical trials submitted between 2019 and 2023, highlights from the analysis showed that one in eight trials tested treatments in humans for the first time. Furthermore, 85 percent were industry sponsored, marking a “strong commercial investment in UK trials”.

Despite these advances, the analysis found that disparities in representation of patient populations. For instance, male-only trials were nearly twice as common as female-only studies. When combined, pregnant and breastfeeding females represented less than two percent of clinical trials in the UK.

Innovative treatments like cell gene and therapies hold promise for patients with limited treatment options, and they represent an expanding area in the clinical landscape. However, these medicines only account for 3.4 percent of UK trials, the report noted.

Enhancing clinical research in the UK

Insights from the report will help to inform future funding, policy and regulation, according to the MHRA.

Similar ongoing initiatives by the MHRA are supporting a wider reform of clinical trials. This includes new clinical trial legislation, which is intended to streamline trials in the UK.

Health Minister Karin Smyth also highlighted more recent initiatives to enhance the country’s clinical trials landscape. “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”.

“… 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,” Science Minister Lord Vallance shared.

“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,” explained Professor Andrea Manfrin, lead author of the study and MHRA Deputy Director, Clinical Investigations and Trials.

MHRA highlighted that the worldwide clinical trials market is expected to nearly double in value by 2032 (over £80 billion).

Findings from the analysis can support development of policies to “bring new medicines to patients, attract investment, accelerate medical innovation, and expand trial access for UK patients”.

This new MHRA report on UK clinical trials follows the World Health Organization (WHO)’s recent confirmation that over the next four years, the agency’s Science and Research group will serve as the one of WHO’s Collaborating Centres for the Standardisation and Evaluation of Biologicals.