On the use of the ratio or the odds ratio of cure rates in therapeutic equivalence clinical trials with binary endpoints.
We discuss in this paper some issues related to the use of the ratio or the odds ratio of cure rates in therapeutic equivalence clinical trials with binary endpoints. Some two one-sided tests procedures are proposed and their fixed sample performances evaluated by Monte Carlo simulations. Sample size formulas are derived for most of these procedures. The consequences of applying acceptance limits proposed for pharmacokinetic responses in bioequivalence studies to clinical endpoints in therapeutic equivalence clinical trials are also described.
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Clinical Trials Group, National Cancer Institute of Canada, Queen's University, Kingston, Ontario, Canada.
D000465:Algorithms; D004358:Drug Therapy; D006801:Humans; D016017:Odds Ratio; D012107:Research Design / Q000706:statistics & numerical data*; D018401:Sample Size; D013810:Therapeutic Equivalency; D016896:Treatment Outcome