Evaluation of irrational dose assignment definitions using the continual reassessment method.

ABSTRACT: BACKGROUND:This article studies the notion of irrational dose assignment in Phase I clinical trials. This property was recently defined by Zhou and colleagues as a dose assignment that fails to de-escalate the dose when two out of three, three out of six, or four out of six patients have experienced a dose-limiting toxicity event at the current dose level. The authors claimed that a drawback of the well-known continual reassessment method is that it can result in irrational dose assignments. The aim of this article is to examine this definition of irrationality more closely within the conduct of the continual reassessment method. METHODS:Over a broad range of assumed dose-limiting toxicity probability scenarios for six study dose levels and a variety of target dose-limiting toxicity rates,

SUBMITTER: Wages NA 

PROVIDER: S-EPMC6904537 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature