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 1 oncology clinical trials. While the potential benefits of assessing PROs in early-phase studies have been acknowledged, the difficulties that arise from such a radical shift have largely been 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 1 oncology trials, with the ultimate goal of facilitating conversations that may help to resolve some of these issues.
