title: An evaluation of Bayesian designs for dose-escalation studies in healthy volunteers.
abstract: In this paper, Bayesian decision procedures previously proposed for dose-escalation studies in healthy volunteers are reviewed and evaluated. Modifications are made to the expression of the prior distribution in order to make the procedure simpler to implement and a more relevant criterion for optimality is introduced. The results of an extensive simulation exercise to establish the properties of the procedure and to aid choice between designs are summarized, and the way in which readers can use simulation to choose a design for their own trials is described. The influence of the value of the within-subject correlation on the procedure is investigated and the use of a simple prior to reflect uncertainty about the correlation is explored.
authors.affiliation: Medical and Pharmaceutical Statistics Research Unit, The University of Reading, Earley Gate, Reading RG6 6FN, UK. j.r.whitehead@reading.ac.uk
authors.forename: John
authors.initials: J
authors.lastname: Whitehead
authors.forename: Yinghui
authors.initials: Y
authors.lastname: Zhou
authors.forename: Adrian
authors.initials: A
authors.lastname: Mander
authors.forename: Sally
authors.initials: S
authors.lastname: Ritchie
authors.forename: Antony
authors.initials: A
authors.lastname: Sabin
authors.forename: Andrew
authors.initials: A
authors.lastname: Wright
mesh_terms: D001499:Bayes Theorem; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D003198:Computer Simulation; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008297:Male; D004364:Pharmaceutical Preparations; D012107:Research Design
chemical_list: D004364:Pharmaceutical Preparations