The utility of partial cross-over designs in early phase randomized prevention trials.
In this note, we outline the benefits of a partial cross-over design for a class of experiments where the interest is the cumulative effect of dose versus placebo. The goal of our design strategy is to answer several complex question efficiently in a phase II setting with a minimal number of assumptions with an eye towards planning a phase III study.
Hutson
Alan D
AD
University at Buffalo, Department of Biostatistics, Farber Hall Room 249A, 3435 Main St., Buffalo, NY 14214-3000, USA.
Reid
Mary E
ME
D017322:Clinical Trials, Phase II as Topic; D018592:Cross-Over Studies; D004311:Double-Blind Method; D006801:Humans; D016032:Randomized Controlled Trials as Topic