Patient-Reported Outcomes to Inform Tolerability Characterization in Cancer Trials: A Critical Perspective on Unresolved Methodological Issues.

Bill Byrom¹, John Devin Peipert^2,3

¹eCOA Science, Signant Health, Blue Bell, PA, USA.

²Department of Applied Health Sciences, University of Birmingham, Birmingham, UK.

³Centre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK.

PubMed PMC DOI PDF

Abstract

Patient-reported outcomes assessing treatment toxicity and its impact, and aspects of quality of life, have become increasingly important components of oncology drug development including early phase dose optimization studies. Despite insights from these data, there are limitations on drawing inferences about whether a treatment is tolerable or intolerable, which requires understanding individual…

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