On the use of the ratio or the odds ratio of cure rates in therapeutic equivalence clinical trials with binary endpoints

Abstract

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 con-sequences of applying acceptance limits proposed for pharmacokinetic responses in bioequivalence studies to clinical endpoints in therapeutic equivalence clinical trials are also described.

Keywords:

• Clinical trials
• Equivalence
• Odds ratio
• Ratio
• Sample size
• Simulations