Precision medicine, immunotherapy, and cellular therapies have reshaped the landscape of oncology, turning once-fatal diagnoses into chronic, or even curable, conditions. These breakthroughs represent extraordinary scientific progress and a deepening understanding of cancer biology. Yet beneath this success runs a quieter, more troubling story. Many patients experience marginal clinical benefit, encounter significant toxicities, or face severe financial strain, while others still lack access to basic treatments. The paradox of modern oncology lies in this coexistence of innovation and inequity.
The Paradox of Progress
The gaps between innovation and access, between surrogate endpoints and lived experience, and between cost and value have become too stark to ignore. These tensions do not diminish the achievements of cancer research, but they compel the oncology community to ask whether progress, as currently defined, truly serves patients. This question lies at the heart of Common Sense Oncology (CSO), a global movement that seeks to align evidence, communication, and policy with outcomes that matter: living longer, living better, and ensuring that everyone, everywhere, can share in those gains.
Conceived in 2022 as a collaboration among clinicians, researchers, and patient advocates, CSO took shape at an international meeting at Queen’s University in Kingston, Canada, where its three foundational pillars—evidence generation, interpretation, and communication—were defined. It was formally launched later that year in The Lancet Oncology through the publication of its manifesto, followed by a 2025 methods paper detailing practical standards for the design, analysis, and reporting of phase III cancer trials.
Voices Behind the Movement
Among the most compelling voices of this initiative is Chris Booth, a Canadian oncologist and health-services researcher whose work has consistently challenged the profession to examine whether cancer care truly delivers value to patients. Booth has written extensively on disparities in global oncology, the limitations of surrogate endpoints, and the ethics of care near the end of life. Together with Bishal Gyawali, he co-founded CSO to restore balance between innovation, evidence, and equity. Among those shaping its international reach, Dario Trapani, an oncologist at the European Institute of Oncology and the University of Milan, has been instrumental in translating its ideals into methodological and ethical practice. As co-author of the Lancet Oncology 2025 Policy Review, Trapani helped formalize CSO’s principles for designing and analyzing phase III trials, insisting on overall survival and quality of life as primary endpoints, transparent reporting of toxicity, and fair choice of control arms. His collaboration with Booth and colleagues has been central to transforming CSO from a critique into a concrete framework—linking methodological rigor, ethical responsibility, and global equity.
The need for such a framework is underscored by the lived experience of patients. Clinical studies show that roughly one in five patients with advanced cancer experiences severe (grade 3–4) treatment-related toxicities, including infections, fatigue, and organ dysfunction. These adverse events often lead to dose reductions, treatment delays, or discontinuations, and are associated with declines in quality of life, functional status, and even survival. Managing toxicity is therefore not merely a matter of safety but a determinant of outcomes: effective cancer care must include the prevention, anticipation, and mitigation of harm through patient-specific risk assessment and robust supportive care.
Time toxicity adds another dimension. Cancer treatment can consume hundreds of hours across multiple appointments, particularly for patients on chronic oral or intravenous regimens. The cumulative time burden erodes patients’ ability to work, care for family, or simply enjoy daily life. In palliative contexts, the trade-off becomes starker: the time spent pursuing treatment may equal or exceed the time it adds to survival. Recognizing this dimension as a form of toxicity reframes decision-making around value and purpose.
Redefining What Counts as Meaningful Benefit
Despite the growing awareness of these issues, clinical research has not always kept pace. A 2025 European Journal of Cancer analysis led by Omar Abdihamid applied the CSO checklist to 55 phase III trials published in 2023, revealing just how wide the gap remains between aspiration and practice. Less than half measured overall survival as a primary endpoint, and only a minority reported quality-of-life data or conducted sensitivity analyses to account for patient dropout. Few acknowledged the time or financial cost to participants. The worth of a therapy, CSO argues, cannot be judged by hazard ratios alone. True value in oncology must include the lived experience of treatment—the physical, emotional, temporal, and financial toll it exacts.
The erosion of endpoints mirrors a deeper cultural drift. Over the past two decades, the proportion of randomized trials using overall survival as their primary measure has sharply declined, replaced by surrogate metrics such as progression-free survival or objective response rate. These indicators may expedite regulatory approval but often fail to capture meaningful benefit. Approvals based on surrogate endpoints can expose patients to toxicity and cost without proven gains in survival or quality of life. The CSO framework insists that such endpoints be used only when validated and interpreted alongside robust patient-reported outcomes, ensuring that the success of a therapy reflects what patients themselves value.
From its inception, CSO has been a deliberately global and multidisciplinary effort, drawing contributors from academic centers, public hospitals, and community oncology practices across North America, Europe, Asia, and the Pacific. It represents not an institution but a movement—a shared commitment to re-centering oncology on outcomes that matter to patients. Its purpose is not to oppose innovation, but to ensure that innovation serves patients meaningfully. CSO calls for stronger evidence generation, more rigorous interpretation of trial data, transparent communication with the public, and a commitment to equity in access. It proposes a disciplined kind of common sense—one that asks of every intervention: Is the benefit meaningful? Is the evidence robust? And is the access fair?
Europe has proven a particularly fertile ground for CSO’s ideas. With its emphasis on universal coverage and value-based health care, the region provides a natural laboratory for testing how innovation and equity can coexist. The European Society for Medical Oncology (ESMO) has long played a central role in shaping Europe’s approach to value, evidence, and fairness in cancer care. Through its Cancer Medicines Committee and initiatives such as the ESMO Magnitude of Clinical Benefit Scale, the society has sought to define meaningful benefit in transparent, reproducible terms. This framework invites decision makers not only to ask whether a drug works, but how much it helps, for how long, and at what cost—to the patient and to the system. Such questions align closely with CSO’s principles, which argue that survival, quality of life, and access must be evaluated together rather than in isolation.
This convergence of priorities was made explicit at the ESMO Congress 2025 in Berlin, where CSO featured prominently within the scientific program. The symposium “Common Sense Oncology: Outcomes That Matter” brought together clinical trialists, health-services researchers, and policy-oriented oncologists from across Europe and beyond. Discussions centered on how to ensure that regulatory evidence is mature and clinically interpretable, how reimbursement can be aligned with genuine patient benefit, and how patients themselves can help define what “benefit” should mean in practice. The visibility of CSO at ESMO marked a turning point: once seen as a critique of excess, it is now part of mainstream European oncology, reshaping how progress is defined, measured, and communicated.
While the principles of Common Sense Oncology have gained broad resonance, translating them into everyday clinical practice is not without difficulty. The modern oncology ecosystem—driven by scientific ambition, regulatory urgency, commercial incentives, and patient hope—does not always align with the measured, patient-centered approach CSO promotes. One concern is that stricter standards of meaningful benefit might slow the pace of innovation or limit early access to new drugs. Yet, as CSO argues, genuine progress depends not on speed but on substance: a therapy that reaches the market quickly but offers only marginal improvement diverts resources from interventions that could provide greater population-level benefit.
Equity remains a stubborn barrier. Even therapies supported by strong evidence often remain out of reach because of cost or infrastructure. CSO extends its principles beyond trial design to the organization of care itself, arguing for transparent, proportionate resource allocation. But its most important message is cultural: progress in oncology should be judged not by novelty, but by meaningful, measurable benefit for patients. CSO invites the oncology community to pause, reconsider, and ensure that every innovation genuinely earns its place in patients’ lives.
About the Author
Prof. Adriana Albini is Co-Editor-in-Chief of CancerWorld Magazine and a Scientific Collaborator at the European Institute of Oncology in Milan. She is the Past Chair of the Cancer Prevention Working Group of the American Association for Cancer Research (AACR) and currently serves as President of European Women’s Management Development.
