title: Dose finding with continuous outcome in phase I oncology trials.
abstract: The goal of a phase I clinical trial in oncology is to find a dose with acceptable dose-limiting toxicity rate. Often, when a cytostatic drug is investigated or when the maximum tolerated dose is defined using a toxicity score, the main endpoint in a phase I trial is continuous. We propose a new method to use in a dose-finding trial with continuous endpoints. The new method selects the right dose on par with other methods and provides more flexibility in assigning patients to doses in the course of the trial when the rate of accrual is fast relative to the follow-up time.
authors.affiliation: Department of Biostatistics, The University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599-7420, USA.
authors.forename: Yunfei
authors.initials: Y
authors.lastname: Wang
authors.forename: Anastasia
authors.initials: A
authors.lastname: Ivanova
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001499:Bayes Theorem; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D003198:Computer Simulation; D004305:Dose-Response Relationship, Drug; D006801:Humans; D020714:Maximum Tolerated Dose; D009369:Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents
keywords: phase I clinical trials; posterior toxicity probability; quasi-likelihood CRM; t-statistics design; toxicity score