title: Type I error probabilities based on design-stage strategies with applications to noninferiority trials.
abstract: When testing the equality of means from two different populations, a t-test or large sample normal test tend to be performed. For these tests, when the sample size or design for the second sample is dependent on the results of the first sample, the type I error probability is altered for each specific possibility in the null hypothesis. We will examine the impact on the type I error probabilities for two confidence interval procedures and procedures using test statistics when the design for the second sample or experiment is dependent on the results from the first sample or experiment (or series of experiments). Ways for controlling a desired maximum type I error probability or a desired type I error rate will be discussed. Results are applied to the setting of noninferiority comparisons in active controlled trials where the use of a placebo is unethical.
authors.affiliation: Food and Drug Administration, Rockville, Maryland 20857, USA. Rothmannm@cder.fda.gov
authors.forename: Mark
authors.initials: M
authors.lastname: Rothmann
mesh_terms: D018849:Controlled Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D006801:Humans; D011336:Probability; D012107:Research Design / Q000706:statistics & numerical data*