An evaluation of Bayesian designs for dose-escalation studies in healthy volunteers

Whitehead, J., Zhou, Y., Mander, A., Ritchie, S., Sabin, A. and Wright, A. (2006) An evaluation of Bayesian designs for dose-escalation studies in healthy volunteers. Statistics in Medicine, 25 (3). pp. 433-445. ISSN 0277-6715 doi: 10.1002/sim.2213

Abstract/Summary

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 proper-ties 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. Copyright (c) 2005 John Wiley & Sons, Ltd.