Patient-Reported Outcomes (PROs) in Early-Phase Oncology Trials

Tapestry Networks has released a new research synthesis examining the use of patient-reported outcomes (PROs) in early-phase oncology drug development. While PROs are well-established in later-phase trials, their application in early development—particularly to inform tolerability and dosing decisions—remains limited, even despite high-level acknowledgement of their potential role in transforming dose optimization by the US FDA and American Society of Clinical Oncology.

This exploratory effort summarized insights from confidential stakeholder interviews and relevant literature to better understand the barriers to early-phase PRO implementation. Interviewees highlighted methodological challenges, organizational and cultural gaps, and mixed regulatory support as key factors influencing the current landscape.

The resulting Summary of Themes is intended to inform the broader community—philanthropic actors, industry leaders, regulators, and researchers—about the opportunities and complexities surrounding PRO use in early oncology drug development to spark dialogue and guide future efforts to improve patient-centered innovation in oncology.

Please view the publication to learn more about the findings and perspectives shaping this important conversation.