Publication

Patient Reported Outcomes in Early Phase Oncology Trials

August 2025

While there are indicators that implementing patient-reported outcomes (PROs) in early phases of oncology drug development may yield meaningful information on tolerability and dosing decisions, industry has yet to adopt such approaches on a large-scale basis. To better understand this lack of uptake, Tapestry Networks engaged in a series of confidential interviews to assess stakeholder perspectives on barriers to early-phase PRO implementation and inform potential opportunities for investment and action by philanthropic actors and others in the community.

This Summary of Themes synthesizes insights from stakeholder interviews and relevant research, including the role of incentives, regulatory policy, implementation challenges and risks, and broader strategic considerations. It also outlines potential opportunity areas for the community to consider in progressing the possible use of PROs in early-phase oncology drug development.