The Hidden Problem in Early Phase Oncology Trials

While 26% of FDA-approved kinase inhibitors required post-marketing dose adjustments, most early-phase oncology trials still rely solely on physician-reported adverse events to determine optimal dosing.

The problem? Physicians consistently underreport patient symptoms – sometimes by 50 times or more.

As a result, patients receive doses that are too high, leading to unnecessary discontinuations and suboptimal outcomes.

The solution? Integrating patient-reported outcome measures (PROMs) into early phase trials to capture the true tolerability profile and optimize dose selection from the start.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/)

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