title: Taking a Measured Approach to Toxicity Data in Phase I Oncology Clinical Trials.
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.
authors.affiliation: Department of Medicine and Committee on Clinical Pharmacology and Pharmacogenomics, University of Chicago, Chicago, Illinois.
authors.forename: Manish R
authors.initials: MR
authors.lastname: Sharma
authors.affiliation: Department of Medicine and Committee on Clinical Pharmacology and Pharmacogenomics, University of Chicago, Chicago, Illinois. mratain@medicine.bsd.uchicago.edu.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Ratain
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D017321:Clinical Trials, Phase I as Topic; D004305:Dose-Response Relationship, Drug; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D020714:Maximum Tolerated Dose; D012107:Research Design
chemical_list: D000970:Antineoplastic Agents