When we began this project, our original goal was to understand how the UK's position in oncology clinical research has evolved over the past quarter century. What we found was a dynamic story, shaped by scientific innovation, Brexit, the COVID-19 pandemic and now, one of the most substantial reforms of UK clinical trial legislation in decades.
Looking beyond the trial numbers only…
One lesson became clear: counting clinical trials alone tells only part of the truth. As countries differ significantly in population size, comparing the UK directly with the United States or China favors larger countries. We therefore examined oncology trial activity from several perspectives, including population-adjusted trial density, phase distribution and funding sources. This approach paints a more nuanced picture.
The UK experienced sustained growth in oncology clinical trials during the early 2000s before reaching a peak around 2017. Subsequent declines coincided with Brexit-related uncertainty and later with disruption caused by COVID-19. Although activity has begun to recover, trial numbers have not yet returned to their previous level.
At the same time, China has undergone remarkable expansion, particularly in early-phase oncology studies, while the United States has maintained exceptional strength in first-in-human and translational research. On the other hand, the European Union continues to generate the largest absolute volume of oncology trials (Figure 1). Rather than identifying a single "winner", our analysis illustrates a rapidly evolving global ecosystem.
It is worth adding that clinical trials environment is being transformed also in other regions. India is emerging as an important geography for global oncology clinical trials, combining large treatment-naïve cancer population, extensive genetic and ethnic diversity, lower trial costs (estimated 40–70% below those in the US and UK), and a growing network of qualified investigators and cancer centers.
Recent regulatory reforms, particularly the New Drugs and Clinical Trials Rules (2019), have created a more predictable and internationally aligned environment, leading to a rapid increase in oncology trial activity while improving trial oversight and patient protection[i].
On the other hand, Latin America accounts for 7.7% of global cancer cases but hosts only 3.6% of oncology clinical trials, highlighting a substantial mismatch between disease burden and research activity. Despite this underrepresentation, the region has significant growth potential because of its evolving regulatory environment, good-quality clinical research infrastructure, and approval timelines comparable to other regions[ii].
Why early-phase oncology matters?
One aspect that particularly interested us was the changing balance between early- and late-phase studies.
Early oncology trials are unlike most other clinical studies. They frequently evaluate first-in-human therapies, rely on sophisticated biomarker strategies, employ adaptive trial designs and often involve patients with advanced cancers who have limited treatment options.
These studies demand an exceptionally efficient research environment. Even relatively small regulatory delays can determine whether an innovative therapy is developed in one country rather than another.
That makes regulatory reform more than an administrative exercise but rather building a scientific competitiveness strategy.
Why 2026 is attracting attention?
One reason we felt this was an important moment to analyze the UK's clinical research landscape is the introduction of the new UK Clinical Trials Regulation in 2026. The reforms aim to streamline approvals, simplify study setup, introduce more proportionate regulation and accelerate timelines for sponsors. Combined review processes, greater use of digital systems and a stronger emphasis on risk-based oversight could make the UK particularly attractive for smaller biotechnology companies and early-phase oncology programs. Whether these ambitions translate into sustained growth remains an open question. Regulation alone cannot guarantee success. Infrastructure, workforce capacity, patients’ recruitment, international collaboration and continued investment will all remain critical.
Competition is becoming global
Perhaps the biggest message from our analysis is that competition in oncology research has become truly international. China has dramatically expanded its oncology research capacity through regulatory reforms, public investment and growing commercial activity. The United States continues to benefit from strong public funding, extensive early-phase infrastructure and an established innovation ecosystem. Within Europe, countries such as Spain and Germany are actively introducing measures to attract more commercial trials. Against this backdrop, maintaining competitiveness requires continuous adaptation rather than relying on historical strengths.
Strengths the UK should not underestimate
Despite recent challenges, the UK retains important advantages. The NHS provides access to comprehensive healthcare data and nationally coordinated research delivery. Networks such as the Research Delivery Network (RDN), Experimental Cancer Medicine Centres (ECMCs) and Clinical Research Facilities continue to support complex oncology studies.
The UK also possesses internationally recognized expertise in translational science, precision oncology, cell and gene therapies, and increasingly, personalized cancer vaccines. These assets are difficult to replicate quickly. The challenge would be ensuring that regulatory improvements are matched by operational efficiency across the clinical research pathway[iii].
Looking beyond traditional drug development
Another exciting observation is how rapidly oncology itself is changing. Today's clinical trials increasingly investigate personalized cancer vaccines, cell therapies, gene therapies and other advanced therapeutic medicinal products (ATMPs). These innovative treatments present new regulatory and logistical challenges, but they also create opportunities for countries with flexible regulatory systems and strong translational infrastructure. The UK's investments in ATMP development, specialized treatment centers and vaccine research could therefore become increasingly important over the coming decade.
Questions rather than conclusions
Perhaps the most valuable outcome of this work is not a definitive conclusion but a series of questions.
- Can faster regulatory approval translate into faster patient recruitment?
- Will early-phase oncology become the UK's distinctive competitive advantage?
- Can academic and commercial research continue to grow together?
- How should countries measure research success: by total trial numbers, research intensity or patient access?
- And perhaps most importantly, how can regulatory innovation be balanced with maintaining scientific quality, patient safety and public trust?
These questions extend far beyond the UK. Many countries are facing similar challenges as oncology drug development becomes increasingly global, increasingly complex and increasingly collaborative.
We'd like to hear your perspective…
Clinical research is shaped by investigators, clinicians, trial managers, patients, regulators and industry partners working together.
If you are involved in oncology drug development, we would be interested to hear your experiences.
- Have recent regulatory changes altered how your organization selects trial locations?
- What remains the biggest obstacle to opening oncology studies?
- Which innovations could most improve trial delivery over the next decade?
- Is regulatory speed becoming the most important factor, or are infrastructure and patient access ultimately more influential?
We hope our analysis contributes to a broader conversation about how countries can build clinical research ecosystems that accelerate innovation while ensuring patients gain timely access to the next generation of cancer therapies.
Figure 1. Comparison of UK, EU, USA and China trial activity in 2025.
Figure presented in the blog have been published in the article: Czajka-Francuz, P., Twelves, C., Spicer, J. et al. Oncology drug development in the UK: analysis of the past 25 years and focus on the 2026 reboot of the clinical trial regulatory framework. Br J Cancer (2026). https://doi.org/10.1038/s41416-026-03543-6
[i] Mankan, A.K., Shankar, A., Limaye, S. et al. Cancer Trials Ecosystem in India-Ready for Prime Time? JCO Glob Oncol. 2024 Jun;10:e2300405. doi: 10.1200/GO.23.00405. PMID: 38870438.
[ii] Nunes Filho, P.R.S., Brandalise, P., Kannan, G.S., et al. J Clin Oncol 42, e23038(2024) suppl.https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e23038
[iii] Czajka-Francuz, P., Twelves, C., Spicer, J. et al. Oncology drug development in the UK: analysis of the past 25 years and focus on the 2026 reboot of the clinical trial regulatory framework. Br J Cancer (2026). https://doi.org/10.1038/s41416-026-03543-6