Brussels, 2 September 2025 – A groundbreaking policy review recently published in the prestigious journal The Lancet Oncology has set a new benchmark in the way health-related quality of life (HRQoL) data is collected, analyzed, and reported in clinical trials for patients with advanced cancer. Spearheaded by renowned oncologists Ian Tannock and Madeline Pe and supported by an international consortium including statisticians, patient advocates, and experts from Common Sense Oncology (CSO) and the European Organisation for Research and Treatment of Cancer (EORTC), this review emphatically underlines the critical need for standardized responder criteria when assessing HRQoL outcomes in cancer research.
Historically, oncology clinical trials have emphasized traditional clinical endpoints such as overall survival (OS) and progression-free survival (PFS), often relegating patient-centered outcomes to a secondary status. This policy review calls for a paradigm shift. It argues that HRQoL should be robustly incorporated as a key secondary endpoint, ensuring that innovations in cancer therapeutics not only extend life but also enhance the lived experience of patients battling advanced-stage malignancies. This approach recognizes that prolonged survival without a commensurate quality of life improvement may fail to meet the fundamental goals of patient care.
Central to the review’s recommendations is a detailed conceptualization of HRQoL as a multi-dimensional construct, objectively measured through patient-reported outcomes (PROs). Specifically, HRQoL should encompass symptom burden—including disease-related and treatment-induced adverse effects—functional domains such as physical, role, and social functioning, and an overarching global HRQoL measure. This holistic framework facilitates nuanced assessment of therapeutic interventions, allowing researchers and clinicians to gauge net clinical benefit by balancing efficacy with tolerability and daily life impact.
One of the most groundbreaking recommendations from the study is the adoption of responder criteria to analyze HRQoL data. Unlike traditional mean score comparisons that often mask inter-patient variability, responder criteria evaluate the proportion of patients experiencing clinically meaningful improvements or deteriorations in quality of life parameters. This shift enables clearer interpretation of trial data, bridging the gap between statistical significance and clinical relevance. Such an approach enhances transparency and supports shared decision-making by providing actionable insights directly relevant to patients and healthcare providers.
The review emphasizes the indispensable role of patient involvement in trial design, especially concerning the selection of which HRQoL domains to assess. Engaging patients ensures that the outcomes measured truly reflect their priorities and lived experiences, thereby improving the validity and acceptability of the research. Collaborating with patients also aligns clinical research with ethical imperatives, fostering respect for patient autonomy and reinforcing the patient-centered ethos in oncology.
Beyond methodology, the authors advocate for improving how HRQoL findings are disseminated. They call for HRQoL results to be published alongside traditional clinical outcomes within the primary trial manuscript rather than relegated to supplementary materials. This practice would increase the visibility of quality-of-life data, encouraging clinicians to integrate these findings into treatment discussions, ultimately influencing real-world decision-making and health policy.
Professor Ian F. Tannock, co-lead author, highlights the transformative potential of these recommendations, stating that understanding the full spectrum of cancer treatment benefits—beyond mere survival—is critical for advancing oncology care. Dr. Madeline Pe further underscores the collaborative spirit that underpinned this consensus, noting that the integration of diverse expertise facilitated a unified framework for presenting HRQoL data, which can seamlessly translate into clinical practice.
The European Organisation for Research and Treatment of Cancer (EORTC), under the leadership of its President Professor Winette van der Graaf, has consistently championed the integration of HRQoL in cancer research. This latest policy review reinforces EORTC’s mission to improve both survival and the quality of that survival for patients living with metastatic or non-resectable cancers. By setting clear standards for HRQoL assessment and reporting, the review lays a foundation for future clinical trials to provide more patient-relevant evidence.
This policy review arrives at a critical juncture in oncology, as precision medicine and novel immunotherapies redefine treatment landscapes. With therapies becoming increasingly tailored, capturing the nuanced impact on patients’ daily functioning and symptom burden is paramount. Standardizing HRQoL responder criteria enhances the ability to compare different therapies and supports regulatory and reimbursement decisions grounded in meaningful patient benefit.
Moreover, the literature review methodology employed by the authors entailed rigorous analysis of existing clinical studies and HRQoL measurement tools, synthesizing evidence across diverse cancer types and treatment modalities. The resulting recommendations represent a comprehensive appraisal of current challenges and best practices, offering pragmatic solutions to longstanding issues in PRO data handling.
Critically, adopting these guidelines could influence not only clinical trial conduct but also post-marketing surveillance and real-world evidence generation, thereby amplifying patient voice throughout the cancer care continuum. A more consistent and transparent approach to HRQoL reporting will foster trust among stakeholders and facilitate more nuanced health technology assessments.
The collaboration between CSO and EORTC exemplifies a successful model of multi-stakeholder partnership, blending scientific rigor with patient advocacy. Their combined efforts emphasize the ethical imperative to design trials that genuinely prioritize outcomes important to patients, advancing a holistic understanding of cancer therapies’ value.
In conclusion, this policy review ushers in a necessary evolution in oncological research frameworks—one that places patients’ quality of life at the core of clinical evaluation. By adopting standardized responder criteria, involving patients in trial design, and emphasizing clear, integrated reporting of HRQoL results, the oncology community can better align research with patient needs. This approach promises to enhance clinical decision-making, optimize treatment selection, and ultimately improve the lived experiences of people confronting advanced cancer.
Subject of Research: People
Article Title: Importance of responder criteria for reporting health-related quality-of-life data in clinical trials for advanced cancer: recommendations of Common Sense Oncology and the European Organisation for Research and Treatment of Cancer
News Publication Date: 1-Sep-2025
Web References:
https://doi.org/10.1016/S1470-2045(25)00288-8
References:
Ian F Tannock, Madeline Pe et al., Importance of responder criteria for reporting health-related quality-of-life data in clinical trials for advanced cancer: recommendations of Common Sense Oncology and the European Organisation for Research and Treatment of Cancer, The Lancet Oncology, Volume 26, Issue 9, 2025, Pages e499-e507
Keywords: Cancer research, Clinical research, Health-related quality of life, Patient-reported outcomes, Advanced cancer, Clinical trials, Responder criteria
