Rethinking Tolerability Measurement in Oncology Trials

Current patient-reported outcome measures in cancer clinical trials capture toxicity severity and its impact on daily life, but do they truly measure whether a patient can tolerate treatment?

In this peer-reviewed commentary published in Cancer Control, Signant Health's Dr. Bill Byrom and Dr. John Devin Peipert examine three critical methodological gaps limiting the value of PRO data in oncology drug development: the absence of evidence-based tolerability thresholds, the lack of validated direct tolerability measures, and the challenge of meaningful baseline assessment using tools like the FACT-G GP5.

With FDA's patient-focused drug development guidance and Project Optimus raising the bar for dose optimization evidence, resolving these gaps has never been more urgent.

Read the commentary for a framework to strengthen the inferential value of PRO endpoints across your oncology program.