Leveraging patient-reported outcome measures for optimal dose selection in early phase cancer trials (Preprint)

UNSTRUCTURED While patient-reported outcome measures (PROMs) are regularly incorporated into phase III clinical trials, there has been little use of PROMs in early phase trials 1. However, the patient perspective is a vital element of fully understanding dose-toxicity and selecting an optimal dose. This viewpoint paper reviews the rationale for, and practical approach to, collection of patient-reported outcomes (PRO) data in early-phase oncology drug development, and the rationale for electronic collection.