The Future of Oncology Trials in the UK: Navigating the UK CTR 2026 Regulatory Reboot
For biotech and pharma sponsors, selecting the optimal geography for an oncology clinical trial is one of the most consequential decisions in the drug development lifecycle. The global landscape is shifting rapidly, and understanding these trends is essential for keeping timelines tight and costs manageable.
A recent landmark analysis published in the British Journal of Cancer-proudly co-authored by Fortrea clinical research specialists alongside leading global oncologists, provides a comprehensive, data-driven look at where oncology research has been over the last 25 years, and more importantly, where it is going.1
Here is what trial sponsors need to know about the shifting global landscape and the UK's impending regulatory reboot.
The Global Landscape: A 25-Year Retrospective
To understand the future, our team analyzed interventional oncology trials registered on ClinicalTrials.gov from 2000 to 2025, comparing the UK against the US, the European Union (EU) and China.
The data revealed several critical shifts for global trial placement:
- The UK's Resilience and Challenges: The UK saw steady growth in oncology trials until 2017. However, the dual impacts of Brexit and the COVID-19 pandemic caused temporary declines.
- The Shifting West: While the US and the EU have maintained high absolute numbers of clinical trials, both regions are experiencing a decline in population-adjusted research intensity. Interesting the UK showed a slower decline than other countries in Europe of the US suggesting that the dynamic for drug development investment in the UK is unique.
- The Rise of China: Unsurprisingly, China demonstrated the fastest growth globally, marked by a substantial increase in trial density and early-phase oncology studies.
As a global CRO operating in more than 100 countries and significant operational capabilities in all these countries, Fortrea sees these trends reflecting an increasingly competitive environment where sponsors must balance overall costs for trial conduct, patient access, regulatory efficiency and operational predictability across geographies.
The 2026 UK CTR: A Catalyst for Early-Phase Oncology?
Despite recent hurdles, the UK retains world-class clinical infrastructure and deep genomic and oncological capabilities. The most exciting takeaway from the publication is the potential impact of the newly implemented New UK Clinical Trials Regulation (UK CTR) of 2026.
There are steps being taken to streamline regulatory processes, harmonize approval pathways, and make the UK a highly competitive destination for clinical research while continuing to assure patient safety. Key changes include the introduction of a notifiable trial pathway for low-risk studies, a faster modification process through Route B, and enhanced support for early-phase and first-in-human (FIH) trials.
The study concludes that this 2026 reboot is uniquely positioned to boost the UK's attractiveness, particularly for early-phase oncology trials.
The UK remains a critical market for clinical research, supported by world-class investigators, integrated healthcare infrastructure, and a strong innovation ecosystem. Fortrea continues to invest in UK-based resources, infrastructure and strategic collaborations to help sponsors capitalize on these strengths.
For sponsors, early-phase trials require rapid start-up timelines, high-quality data capture and access to specialized key opinion leaders (KOLs). The modernized UK framework aims to deliver exactly that, offering a highly viable alternative to the increasingly saturated US and EU markets.
Achieving these goals requires close collaboration across the clinical research ecosystem. Fortrea works alongside healthcare professionals and investigators to support efficient study start-up, predictable execution and high-quality delivery through its specialised site network like the Early Phase Oncology Network (EPON) for which the UK has significant representation.
What This Means for Your Next Study
Because Fortrea didn't just read this research, we helped author it; we bring both scientific insight and operational experience to sponsors navigating today's oncology landscape. Our global footprint, UK capabilities and collaborative relationships help sponsors translate emerging opportunities into successful clinical trial execution.
As oncology development becomes increasingly global, the most successful trials will be built on collaboration—bringing together sponsors, healthcare professionals, investigators, research institutions, and CRO partners to accelerate innovation and improve outcomes for patients worldwide. Our global footprint spanning more than 100 countries, combined with our UK capabilities and established collaborations across the clinical research ecosystem, enables us to help sponsors design and deliver studies with greater speed, predictability and quality.
Ready to discuss your global oncology strategy?
Connect with our clinical development team today to learn how the 2026 regulatory changes could impact your specific pipeline and how Fortrea can help optimize your global oncology development strategy.