title: Some notable properties of the standard oncology Phase I design.
abstract: We identify three properties of the standard oncology Phase I trial design or 3 + 3 design. We show that the standard design implicitly uses isotonic regression to estimate a maximum tolerated dose. We next illustrate the relationship between the standard design and a Bayesian design proposed by Ji et al. (2007). A slight modification to this Bayesian design, under a particular model specification, would assign treatments in a manner identical to the standard design. We finally present calculations revealing the behavior of the standard design in a worst case scenario and compare its behavior with other 3 + 3-like designs.
authors.affiliation: Department of Statistics, University of California, Berkeley, California, USA. ghather@berkeley.edu
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Hather
authors.forename: Howard
authors.initials: H
authors.lastname: Mackey
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage*; D017321:Clinical Trials, Phase I as Topic / Q000379:methods* / Q000592:standards* / Q000706:statistics & numerical data; D006801:Humans; D020714:Maximum Tolerated Dose; D008495:Medical Oncology / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D012044:Regression Analysis; D012107:Research Design / Q000592:standards* / Q000706:statistics & numerical data
chemical_list: D000970:Antineoplastic Agents