Some extensions and applications of a Bayesian strategy for monitoring multiple outcomes in clinical trials.
We present some practical extensions and applications of a strategy proposed by Thall, Simon and Estey for designing and monitoring single-arm clinical trials with multiple outcomes. We show by application how the strategy may be applied to construct designs for phase IIA activity trials and phase II equivalence trials. We also show how it may be extended to incorporate the use of mixture priors in settings where a Dirichlet distribution does not adequately quantify prior experience, randomized phase II selection trials involving two or more experimental treatments, and trials with group-sequential monitoring for applications involving multiple institutions.
Thall
P F
PF
Department of Biomathematics, University of Texas M.D. Anderson Cancer Center, Houston 77030, USA. rex@odin.mdacc.tmc.edu
Sung
H G
HG
D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001499:Bayes Theorem; D017322:Clinical Trials, Phase II as Topic / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D006801:Humans; D008432:Mathematical Computing; D015233:Models, Statistical; D010043:Outcome and Process Assessment, Health Care / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012107:Research Design
D000970:Antineoplastic Agents