The Hidden Problem In Early Phase Oncology Trials

By Bill Byrom, PhD; Anthony Everhart, MD; Paul Cordero, PhD; Chris Garratt, MBChB; Tim Meyer, MBBS, PhD

Early phase oncology trials have long relied on clinician-reported adverse events to guide dose selection, often overlooking the patient’s lived experience. Integrating patient-reported outcome measures (PROMs) can enable studies to better capture tolerability and optimize dosing decisions—especially for modern targeted therapies with longer treatment durations. Evidence displayed in this paper shows that physicians consistently underreport or underestimate adverse events compared to patients, risking overexposure to toxic doses. Explore how practical strategies for PROM implementation, including tailored item sets, electronic data capture, and weekly assessments, can minimize burden. By incorporating tools like PRO-CTCAE, FACT GP5, and EORTC QLQ-C30, researchers can gain a more complete picture of treatment impact. For trials aiming to balance efficacy with patient quality of life, this approach offers a compelling path forward.

© Byrom B, Everhart A, Cordero P, Garratt C, Meyer T Leveraging Patient-Reported Outcome Measures for Optimal Dose Selection in Early Phase Cancer Trials JMIR Cancer 2025;11:e64611 URL: https://cancer.jmir.org/ 2025 /1 /e64611 doi: 10.2196/64611