Test for the Consistency of Noninferiority from Multiple Clinical Trials

Abstract

A testing procedure is proposed to assess the consistency of noninferiority from a collection of trials based on simultaneous t lower confidence bounds or Scheffé's lower confidence bounds. Methods for simultaneous inferences on pairwise or many-to-one comparisons among multiple noninferiority trials are also discussed. To avoid bias due to subjective trial exclusion a tuning parameter k is embedded into the testing procedure to provide flexibility to quantify the "consistency of noninferiority" when the total number of trials is large. The size and power of the proposed test are discussed. The method is illustrated using simulations and real data analysis.