The UK Medicines and Healthcare products Regulatory Agency (MHRA) claims the UK is again a global leader in clinical trials.
As part of the project, in collaboration with the University of Liverpool, the MHRA has published a paper in the British Journal of Clinical Pharmacology, which provides a deep insight into the UK’s clinical trials landscape.
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The MHRA believes this is the first analysis conducted by a UK regulator to evaluate clinical trial submissions.
Report findings
Between February 2019 and October 2023, the MHRA Clinical Trials Unit (CTU) received 4,616 initial clinical trial submissions, with the highest percentage in 2020 and the lowest in 2023. Of those, Phase III submissions were the most common, and approximately 85% of clinical trial submissions were from commercial sponsors.
Both sexes were represented in most trials, with male-only trials being twice as common as female-only trials. Regarding the diversity of participants, the elderly were represented more commonly than adults (aged 18–64 years), with teenagers being the most studied paediatric population.
Breastfeeding and pregnant women were present in very low percentages and were most likely to be recruited to Phase III and IV trials.
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By GlobalDataTrials involving healthy volunteers represented less than a fifth of the total submissions, and these were most commonly Phase I trials.
The most common indication was cancer, making up nearly a third of all studies. Many indications however are lacking behind, for example, 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.
Researchers say this evaluation shows that despite Lord James O’Shaughnessy’s previous evaluation of the UK clinical trial landscape, pharmaceutical and biotech companies invest heavily in clinical trials in the UK to develop new drugs and therapies. In 2023, Lord O’Shaughnessy’s report found that the UK had a 44% reduction in commercial clinical trial initiation in the five years before, dropping from fourth to tenth as global contributors to clinical trials.
Impact on research
The MHRA said the data will be used to build on the strengths of the UK clinical trial space to maintain its global presence.
This research has already been used to support the development of the new regulatory framework for clinical trials, which aligns with Lord O’Shaughnessy’s recommendations suggesting that the MHRA should continue adapting its regulatory processes to ensure that the UK remains at the forefront of clinical trial innovation.
MHRA CEO Lawrence Tallon said: “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.”
The MHRA will also use the report to build on this progress and deliver the clinical trial regulations to create a more efficient, streamlined and adaptable regulatory framework.
This includes increasing research into underrepresented conditions, improving diversity, and attracting further global investment in innovation, with help from patients, the National Health Service (NHS), industry and academia.
Earlier this week, the UK Government announced $764m (£600m) in funding to support a new health data service to support researchers across the country.
