Optimization of testing times and critical values in sequential equivalence testing

✍ Scribed by Hans-Helge Müller; Helmut Schäfer

• Publisher: John Wiley and Sons
• Year: 1999
• Tongue: English
• Weight: 167 KB
• Volume: 18
• Category: Article
• ISSN: 0277-6715
• DOI: 10.1002/(sici)1097-0258(19990730)18:14<1769::aid-sim213>3.0.co;2-h

✦ Synopsis

In long-term clinical trials, interim analyses are planned to reduce the number of patients needed. To meet this issue in a practical way, group sequential designs are used. Most of these trials are conducted with the objective of demonstrating di!erences in e$cacy of treatments, for example, to show superiority of a new drug or experimental treatment to a control. However, an increasing number of trials are designed to establish equivalence in e$cacy or bioequivalence. This paper deals with group sequential test procedures in two-sided equivalence trials. Optimized designs with respect to sample size behaviour are constructed. Tables containing optimal testing times and corresponding optimal critical values or values to construct an underlying -spending function, respectively, are provided. An example illustrates their use when planning interim analyses in equivalence trials.