Common sense oncology values to action: a patient-led framework for randomized clinical trial design.

BACKGROUND

Randomized controlled trials are the foundation of oncology drug development, yet increasing concern exists that some prioritize regulatory approval over outcomes that matter to patients. The Common Sense Oncology (CSO) initiative was founded to reorient research toward patient-valued endpoints. The CSO Patient Priorities Working Group sought to codevelop a pragmatic, patient-centered framework articulating values and actions to guide the design, conduct, and reporting of oncology randomized controlled trials.

METHODS

A multiphase, mixed-methods process included literature review, thematic analysis, and international stakeholder engagement. Eight focus groups were held between April 2024 and January 2025 with 131 participants across 7 countries, including people with lived cancer experience, advocates, clinicians, and trialists. Feedback from surveys and structured discussions-quantitative ratings and qualitative insights-informed iterative framework refinement.

RESULTS

The final framework defines 9 core values with associated actions: meaningful research question, patient partnerships, informed consent, meaningful benefit, generalizability, optimal comparator arm, minimal participant burden, timely feedback of results, and clear dissemination. All values received high endorsement (median 8-9 on a 9-point numeric rating scale [from 1 (least important) to 9 (most important)]). Qualitative analysis emphasized meaningful endpoints, transparent communication, equitable inclusion, fair compensation, and plain-language consent.

CONCLUSIONS

The CSO Values to Action Framework provides a validated, internationally informed structure for trialists, ethics boards, funders, and advocates. It offers a practical tool to align oncology research with what matters most to patients, promoting more ethical, inclusive, and relevant clinical trials.