Abstract <b>PS5-11-11</b> : <b>A common sense oncology values-to-action framework for patient-centered randomized trials in oncology</b>

Abstract Background: Despite advances in oncology, too many randomized clinical trials (RCTs) fail to answer the most meaningful question: does this intervention improve the lives of people with cancer? Many trials prioritize regulatory approval pathways, rely on surrogate endpoints with limited patient relevance, and impose burdensome protocols that deter participation—particularly from underrepresented populations. This project aimed to develop a globally informed, patient-centered framework to guide the design and conduct of oncology RCTs and explicitly bring the patient voice into trial planning and decision-making. Methods: We conducted a multi-phase, mixed-methods development process that included literature review, thematic analysis, and international stakeholder engagement. We conducted a scoping review of published and grey literature, patient rights charters, and existing frameworks to identify gaps in patient-centered trial guidance. A draft “Values to Action” framework was developed through thematic synthesis by two authors and revised in collaboration with an international working group. After an initial pilot in New Zealand, seven focus groups were held between April 2024 and January 2025 with individuals affected by cancer in India, the United States, Canada, Europe, South Africa, Ghana, and Brazil. Prior to each session, participants received a survey assessing the importance of each value and associated action on a 9-point Likert scale, along with opportunities for open-text comments. Focus groups, conducted virtually, explored areas of consensus and divergence and generated qualitative feedback for refinement. Quantitative analysis included descriptive statistics and non-parametric group comparisons by age, gender, region, and income level. Thematic analysis of qualitative data from survey comments and discussion transcripts was used to iteratively revise the framework. Results: We received 59 eligible survey responses from the pilot and 72 from the seven subsequent focus groups. Participants were geographically diverse: 19 (26.4%) from the U.S., 17 (23.6%) from India, 15 (20.8%) from Canada, 12 (16.7%) from Brazil, and 9 (12.5%) from African and European countries; 52.8% were from high-income countries. Half were cancer survivors, 12.5% were living with metastatic disease, and others were caregivers or had other experiences of cancer. Quantitative ratings showed strong agreement across all values and actions (median=9). The action with the lowest median score (median=8)—concerning restrictive exclusion criteria—also had the highest frequency (18%) of neutral responses (scores 4-6). Very few items were rated “not important” (scores 1-3), primarily those related to diversity, exclusion, burden of trial related procedures, and compensation for costs incurred. Themes from qualitative analysis emphasized the importance of meaningful endpoints, transparent communication, equitable inclusion, fair compensation, and plain-language informed consent. The final framework consists of nine core values with associated actions. Conclusions: Patients strongly support trial endpoints that reflect real-world impact, including overall survival and quality of life, over surrogate markers such as radiographic response. Our framework reflects a broad, international consensus on what constitutes a patient-centered oncology trial, including a strong emphasis on co-design, consent, and broad inclusion criteria. The resulting framework can serve as a practical guide for patient advocates involved in reviewing trials as well as trialists, ethics committees, funders, and regulators. This work is especially relevant to the breast cancer field, where advocates have long influenced research priorities and trial design. The framework can help extend this impact globally. Citation Format: M. Tregear, H. Verduzco-Aguirre, B. Shkabari, V. Venkatesh, R. Chidebe, B. Sirohi, R. Koven, H. Scowcroft, B. Gyawali, M. Brundage, E. Eisenhauer, C. Booth, C. Jackson. A common sense oncology values-to-action framework for patient-centered randomized trials in oncology [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-11-11.