Taking a Measured Approach to Toxicity Data in Phase I Oncology Clinical Trials.

Sharma, Manish R; Ratain, Mark J · Clin Cancer Res · 2016

expert_opinion · Level V

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Abstract

The standard categorical system for assessing attribution of toxicity to study drug(s) in phase I trials is cumbersome and uninformative. Although a binary system ("related" vs. "unrelated") would be sufficient to define maximum tolerated dose (MTD), a probability estimation would better support dose selection for randomized dose-ranging phase II trials.

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