Assessment of Patient-Reported Outcomes in Industry-Sponsored Phase I Oncology Studies: Considerations for Translating Theory Into Practice.

An increasing interest in the identification of optimal dosage for oncology therapies has prompted key opinion leaders and regulators to encourage the integration of patient-reported outcome (PRO) assessments in phase I oncology clinical trials. Although the potential benefits of assessing PROs in early-phase studies have been acknowledged, the difficulties that arise from such a radical shift have been largely overlooked in the public discussion. In this commentary, the authors provide insight into the challenges that industry sponsors face in integrating PRO assessments into phase I oncology trials, with the ultimate goal of facilitating conversations that may help to resolve some of these issues.