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. • Patient-reported outcomes (PROs) are rarely assessed in phase I oncology studies, although recent initiatives from Food and Drug Administration encourage their use. • There are both benefits and challenges associated with assessing PROs in early-phase oncology trials. • To be successful, integration of PRO assessments in phase I oncology clinical trials requires an acknowledgment of the challenges industry sponsors face and realistic approaches to resolve these issues. [ABSTRACT FROM AUTHOR]