• Clin Cancer Res · Feb 2016

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

    • Manish R Sharma and Mark J Ratain.
    • Department of Medicine and Committee on Clinical Pharmacology and Pharmacogenomics, University of Chicago, Chicago, Illinois.
    • Clin Cancer Res. 2016 Feb 1; 22 (3): 527-9.

    AbstractThe 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.©2015 American Association for Cancer Research.

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