Access to cancer clinical trials in Europe: when trial availability does not match patient need

The central thesis posited by the European Society For Medical Oncology (ESMO) Industry Strategic Forum (EISF) report on the European oncology clinical trial landscape reveals that there is misalignment between patient needs and trial availability in Europe.¹ Clinical trials are not peripheral or ancillary to cancer care. They turn promising treatments into standards, discard ineffective ones, and generate the evidence that solves clinical uncertainty. For some patients, particularly after standard options have been exhausted, a trial may also offer the opportunity to try some new upcoming treatment options. Access to trials could therefore be considered a metric of high-quality cancer care.

The ESMO report makes this ‘access to trials’ issue quite conspicuous. It identified 3147 oncology trials conducted from 2019 to 2024 across Europe and converted them into 9885 country-level trial entities, to analyze country-level access to trials.¹ For example, one multinational trial open in five countries would constitute five country-level entities. The report highlights several important findings. In absolute terms, Spain, France, and Italy account for the largest numbers of country-level trial entities, with 1380, 1271, and 1022 trials, respectively.¹ When trial activity is adjusted for population, however, Belgium and Denmark have the highest densities, at 5.8 and 5.2 trial entities per 100 000 inhabitants, followed by the Netherlands at 3.5 and Spain at 2.9, whereas Germany and the United Kingdom appear to be less prominent after population adjustment.¹ This divergence between total trial activity and access density has consequences for patients. Large research systems may generate many trials while still leaving substantial parts of their population with limited access. Within Eastern Europe, Hungary has the highest trial density reported in the ESMO analysis at 2.8 trial entities per 100 000 inhabitants, whereas Romania has the lowest at 0.9.¹ Belgium and Denmark have roughly six times Romania’s trial density. We refer to this poor alignment between oncology trial availability and cancer burden across Europe as the ‘trial access gap’.

Although imperfect, this ‘trial access gap’ analysis captures something clinically meaningful—whether a patient might realistically encounter a trial through the health system in which they are treated and therefore should be considered as a part of Europe’s broader cancer inequalities agenda. Inequality in cancer care focuses usually only on disparities in access to prevention, diagnosis, treatment, or survivorship; we strongly argue that disparities in access to clinical trials, and cancer research more broadly, should also be considered under this domain. Europe’s Beating Cancer Plan and the European Cancer Inequalities Registry have already made disparities in screening uptake, stage at diagnosis, access to radiotherapy and innovative medicines, and cancer survival more visible and more measurable across countries, regions, and socioeconomic groups.^2,3 Clinical research should be held to a similar standard. A country cannot be considered well served by cancer innovation if its patients have little chance of entering the studies that define the standards of care.

However, this trial access gap is unlikely to reflect regulatory delay or sponsor preference alone. Infrastructure, investigator networks, contracting capacity, molecular diagnostics, and referral pathways all contribute. Yet in lower-density systems, the barriers are also structural, including limited trial education, weaker clinical trial units, and site-level incentives that favor better-funded commercial studies over independent academic trials. As a result, patients in these systems may be less likely to be offered trial participation, less likely to access early innovation, and less likely to be represented in the evidence that later guides care. Closing the trial access gap therefore requires sustained research capacity building, rather than redistribution of trial sites.^4,5

Indeed, not all clinical trials are created equal and access to meaningful patient-centric trials is not the same as access to any trials. Furthermore, industry-sponsored trials are often driven by strategic priorities that may not fully align with the most pressing clinical needs. Therefore, expanding the trial infrastructure is necessary but not sufficient. A policy response that only increases the number of industry-sponsored late-phase drug trials in under-represented countries could improve visible access metrics without building a durable research ecosystem. What is needed is sustained capacity for investigator-initiated, pragmatic, treatment optimization, de-escalation, radiotherapy, surgical, supportive care, and translational studies that answer questions relevant to each health system. These are often the studies most likely to improve routine care yet they are also the least commercially attractive and the most exposed to administrative burden.

Ultimately, simply counting the number of trials is an insufficient measure of progress. Access to early-stage, low-impact, poorly designed clinical trials chasing small magnitudes of benefit or using unethical control treatments does not equate to meaningful participation in research. Health systems must be equipped not only to host trials but also to design and conduct studies that generate actionable evidence and improve patient care.

There is a further inequity that the ESMO report cannot capture, because it shows where trials are open but cannot show who is enrolled once a trial exists. Older adults, patients with comorbidities, people from lower socioeconomic groups, rural communities, migrants, and ethnic minorities remain under-represented in oncology trials.^6,7 These groups may live in countries with substantial trial activity and still never reach those studies. Therefore, patient support should be a part of any serious trial access strategy but it must be framed carefully. Patients should not incur additional avoidable costs generated by research participation, such as trial-specific procedures, extra visits, cross-border referral, translation, or lodging. At the same time, this should not mean transferring all routine-care costs to sponsors, particularly in Europe where transport, parking, and caregiver support are handled differently across health systems. For publicly funded clinical trials that aim to optimize care, health care systems should consider solutions to minimize the financial impact on patients for trial-specific procedures, in addition to the standard care. Recent evidence that patients may experience financial toxicity during trial participation, even when treatment itself is provided at no cost, reinforces why these barriers cannot be dismissed.⁸ If they remain unaddressed, trial availability on paper will continue to overstate access in practice.

Part of the policy machinery is already in place and the Clinical Trials Regulation has created a harmonized framework for authorization through a single EU portal and assessment process.⁹ Accelerating Clinical Trials in the European Union (ACT EU) aims to make Europe more attractive for high-quality clinical research and to better integrate trials into health systems.¹⁰ We acknowledge that faster authorization and better coordination are welcome but these measures alone will not close the trial access gap. The system should distinguish between pivotal trials seeking registration of new drugs or devices and pragmatic, low-risk trials seeking optimization of existing established treatments. For experienced academic networks, the problem is often not how to navigate the current system but whether the current system remains proportionate for pragmatic, low-risk, treatment optimization, or nondrug trials. Risk-based implementation may help but it cannot fully compensate for regulatory requirements that are too burdensome for independent multinational research. Europe therefore needs operational support and legislative simplification, including a more workable pathway for low-risk academic trials. Europe should judge these reforms by whether they make independent, clinically relevant multinational trials feasible in countries that currently participate too little in cancer research.

The EU clinical trial map is a useful step because it makes trial geography more visible to patients, clinicians, and policymakers.¹¹ However, it also exposes a limitation of the current infrastructure. The Clinical Trials Information System is built around clinical trials of medicinal products, while many surgical, radiotherapy, diagnostic, supportive care, and care-delivery studies are not captured in the same way.^9,11 This drug-centered architecture matters because independent academic trials remain structurally disadvantaged in Europe, even though ACT EU notes that ∼40% of clinical trials are sponsored by academia or other noncommercial sponsors, with these studies often being small and uninational.¹² Academic sponsors usually work with narrower budgets, smaller administrative teams, and less capacity to sustain cross-border monitoring, contracting, pharmacovigilance, and data-management requirements. Yet, multinational independent trials are essential for questions that individual countries cannot answer alone, particularly in the domains of rare cancers, radiotherapy and surgical strategies, de-escalation, treatment sequencing, supportive care, and treatment optimization. If trial access becomes a formal cancer equity indicator, Europe should measure access to clinically meaningful research across modalities and make multinational academic research easier to conduct, because these are often the studies most aligned with patient and health-system needs.

The 2025 Institute for Health Economics Comparator Report reinforces that the trial access gap is also a strategic evidence problem for Europe. The report notes that Europe’s share of global oncology trials has declined substantially and that fewer trials are being conducted within European health care systems.¹³ This is important because reimbursement agencies, clinicians, and patients need evidence on relative effectiveness, cost-effectiveness, and optimal use in their own settings. A European trial access agenda should therefore not focus only on opening more studies; it should also protect Europe’s capacity to generate independent, health-system-relevant evidence.

It is noteworthy that inequity in access to cancer clinical trials is not a uniquely European problem. Recent analyses from the United States describe a parallel pattern of structural barriers to trial access, and American Society of Clinical Oncology has called for coordinated action to address them.^14,15 Acknowledging this parallel confirms that trial access should be treated as a core dimension of cancer care equity.

The EISF report should therefore be read as more than a descriptive exercise, as earlier analyses have already documented inequalities in oncology trial access across Europe and globally.^16,17 Its value lies in making those inequalities visible in a form that can be tracked over time and acted upon. Clinical trial access should be reported annually alongside incidence, mortality, stage at diagnosis, and treatment capacity. However, the indicator should not be reduced to a count of drug trials. It should distinguish commercial and noncommercial sponsorship, early- and late-phase studies, academic and pragmatic trials, and research across treatment modalities. The report’s map should be translated into explicit targets for low-density countries and regions, paired with investments in education, clinical trial units, data infrastructure, fair site reimbursement, and proportionate regulation for low-risk academic studies. A simple count of trials, however, is not the right yardstick; the goal should be access to research that meaningfully changes practice. Europe can claim leadership in cancer research only if patients across Europe have a credible route into that research. Otherwise, excellent evidence will continue to be generated in places many patients will never reach.