Introduction
toxicities, DLTs, Cancer
ADVERSE EVENT, CANCER
This article considers the concept of designing Phase I clinical trials using both clinician and patient-reported outcomes (PROs) to adaptively allocate study participants to tolerable doses and determine the maximum tolerated dose (MTD) at study conclusion. In addition to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) for capturing dose-limiting toxicities (DLTs) evaluated by clinicians, the patient-reported outcomes (PRO)-CTCAE provides an instrument for capturing PRO-DLTs that can also be used in determining the MTD. The PRO-CTCAE is made up of 124 items, including 78 symptomatic toxicities from the CTCAE [Lee, Lu, and Cheng [This article describes an application of a Bayesian form of the PRO-CRM [