Statistical procedures in therapeutic equivalence clinical trials with ordinal categorical clinical endpoints
D. Tu (2001). Statistical procedures in therapeutic equivalence clinical trials with ordinal categorical clinical endpoints. Journal of Statistical Research, Vol. 35, No. 1, pp. 65-77.
There is an increasing number of clinical trials conducted in recent years with the objective to show that a test therapy is equivalent in efficacy to a standard or reference therapy. In this paper we consider therapeutic equivalence clinical trials where the clinical endpoints are ordered categorical. Some statistical procedures based on the Wilcoxon statistic or a proportional odds model are introduced in this paper. These procedures are illustrated and compared through the data from an equivalence clinical trial. conducted by a generic drug company in support of its application for marketing the generic copy of a brand name drug. The sample size determinations based on asymptotic two one-sided tests procedure are also discussed in this paper.