ABSTRACT

The multiplicity can come from different sources in clinical trials, it can come from multiple-treatment comparisons, multiple tests performed at different times, multiple tests for several endpoints, and multiple tests conducted for multiple populations using the same treatment within a single experiment. Multiple time-point analyses are often conducted in longitudinal studies with repeated measures, or in trials with group sequential or adaptive designs. Single-step progressive parametric multiple testing is a special singlestep but powerful test method for multiple testing problems with normal endpoint. Stepwise procedures are different from single-step procedures in the sense that a stepwise procedure must follow a specific order to test each hypothesis. There are four categories of stepwise procedures which are dependent on how the stepwise tests proceed: fixed-sequence, stepup, stepdown, and fallback procedures. The Holm procedure is based on a data-driven order of testing, while the fixed-sequence procedure is based on a prefixed order of testing.