An evaluation of Bayesian designs for dose-escalation studies in healthy volunteers.
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.
Whitehead
John
J
Medical and Pharmaceutical Statistics Research Unit, The University of Reading, Earley Gate, Reading RG6 6FN, UK. j.r.whitehead@reading.ac.uk
Zhou
Yinghui
Y
Mander
Adrian
A
Ritchie
Sally
S
Sabin
Antony
A
Wright
Andrew
A
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
D004364:Pharmaceutical Preparations