Oncology drug development in the UK: analysis of the past 25 years and focus on the 2026 reboot of the clinical trial regulatory framework

OBJECTIVES: The aim of the article was to analyse the trends in oncology interventional clinical trials in the United Kingdom (UK) from 2000 to 2025, compare with major global regions, and to assess the potential impact of the New UK Clinical Trials Regulation (UK CTR) 2026 regulatory reform on the future competitiveness. DESIGN: Retrospective observational analysis of interventional oncology trials registered on ClinicalTrials.gov with comparison across the UK, European Union (EU; comprising 27 member states), the United States, and the Republic of China (China). MAIN OUTCOME MEASURES: Number of trials, phase distribution, funding source, and population-adjusted trial density across three time intervals (2000-2015, 2016-2020, 2021-2025). RESULTS: The UK experienced growth in oncology trials until 2017, followed by declines associated with Brexit and the COVID-19 pandemic, and partial recovery thereafter. While the EU and USA maintained high absolute trial numbers, both showed declining population-adjusted research intensity over time. China demonstrated the fastest growth, with substantial increases in early phase trials and trial density. CONCLUSIONS: Despite recent challenges, the UK retains strong infrastructure and expertise in oncology research; the 2026 regulatory reform may support the future attractiveness of the UK, particularly for early phase trials, although increasing global competition remains a significant issue.

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Publication Details

Journal
British Journal of Cancer
Published
2026-07-23
DOI
https://doi.org/10.1038/s41416-026-03543-6
Primary Topic
Ethics in Clinical Research
Type
article
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article

Oncology drug development in the UK: analysis of the past 25 years and focus on the 2026 reboot of the clinical trial regulatory framework

Sharan Sandhu, Vikram Bohra, Gopalakrishnan Srinivasan, Kamal S. Saini et al.
British Journal of Cancer
Ethics in Clinical Research
article

Oncology drug development in the UK: analysis of the past 25 years and focus on the 2026 reboot of the clinical trial regulatory framework

Sharan Sandhu, Vikram Bohra, Gopalakrishnan Srinivasan, Kamal S. Saini, Raghib Ali, Laura Vidal, Fiona Thistlethwaite, Chris Twelves, Paulina Czajka‐Francuz, James Spicer, Ruth Plummer, Glen Clack, Soma Das, Sarah P. Blagden, Dinesh Mistry, Debashis Sarker, Suvarna Chavan, Archana Munje, Chinmayee Joshi, Jim Bush, Thomas R. Jeffry Evans, Michael George, Ken Morrison, Andrew Walding, Maksym Novikov
article en

Abstract

OBJECTIVES: The aim of the article was to analyse the trends in oncology interventional clinical trials in the United Kingdom (UK) from 2000 to 2025, compare with major global regions, and to assess the potential impact of the New UK Clinical Trials Regulation (UK CTR) 2026 regulatory reform on the future competitiveness. DESIGN: Retrospective observational analysis of interventional oncology trials registered on ClinicalTrials.gov with comparison across the UK, European Union (EU; comprising 27 member states), the United States, and the Republic of China (China). MAIN OUTCOME MEASURES: Number of trials, phase distribution, funding source, and population-adjusted trial density across three time intervals (2000-2015, 2016-2020, 2021-2025). RESULTS: The UK experienced growth in oncology trials until 2017, followed by declines associated with Brexit and the COVID-19 pandemic, and partial recovery thereafter. While the EU and USA maintained high absolute trial numbers, both showed declining population-adjusted research intensity over time. China demonstrated the fastest growth, with substantial increases in early phase trials and trial density. CONCLUSIONS: Despite recent challenges, the UK retains strong infrastructure and expertise in oncology research; the 2026 regulatory reform may support the future attractiveness of the UK, particularly for early phase trials, although increasing global competition remains a significant issue.

British Journal of Cancer
AstraZeneca (United Kingdom) (GB), National Health Service (GB), Guy's Hospital (GB), University of Leeds (GB), Universiti Sains Malaysia (MY), King's College London (GB), Leeds Teaching Hospitals NHS Trust (GB), Beatson West of Scotland Cancer Centre (GB), Churchill Hospital (GB), Cancer Research UK (GB), Newcastle upon Tyne Hospitals NHS Foundation Trust (GB), Cambridge University Hospitals NHS Foundation Trust (GB), University of Manchester (GB), University of Oxford (GB), London Cancer (GB), East Suffolk and North Essex NHS Foundation Trust (GB), Cancer Research UK Manchester Institute (GB), The Christie NHS Foundation Trust (GB), MRC Epidemiology Unit (GB), University of Glasgow (GB), Newcastle University (GB), University of Sheffield (GB)
Openalex Percentile: Top 8%
Ethics in Clinical Research
DOIOpen Access PDFOpenAlex
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