Premium
Testing Superiority and Non‐Inferiority Hypotheses in Active Controlled Clinical Trials
Author(s) -
Tsong Yi,
Zhang Juan Joanne
Publication year - 2005
Publication title -
biometrical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.108
H-Index - 63
eISSN - 1521-4036
pISSN - 0323-3847
DOI - 10.1002/bimj.200410089
Subject(s) - statistical hypothesis testing , econometrics , psychology , statistics , medicine , mathematics
Switching between testing for superiority and non‐inferiority has been an important statistical issue in the design and analysis of active controlled clinical trial. In practice, it is often conducted with a two‐stage testing procedure. It has been assumed that there is no type I error rate adjustment required when either switching to test for non‐inferiority once the data fail to support the superiority claim or switching to test for superiority once the null hypothesis of non‐inferiority is rejected with a pre‐specified non‐inferiority margin in a generalized historical control approach. However, when using a cross‐trial comparison approach for non‐inferiority testing, controlling the type I error rate sometimes becomes an issue with the conventional two‐stage procedure. We propose to adopt a single‐stage simultaneous testing concept as proposed by Ng (2003) to test both non‐inferiority and superiority hypotheses simultaneously. The proposed procedure is based on Fieller's confidence interval procedure as proposed by Hauschke et al. (1999). (© 2005 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)