Choice of λ-margin and dependency of non-inferiority trials

Statistics in Medicine

Volumn 27, Issue 4, 2008, Pages 520-528

  Tsong, Yi ^a   Levenson, Mark ^a   Zhang, Joanne ^a   Zhong, Jinglin ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Cross trial comparison approach; Dependency of two trials; Non inferiority margin; Non inferiority test; Percentage of retention

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CORRELATION ANALYSIS; DRUG RESEARCH; HYPOTHESIS; INFERIORITY TEST; MATHEMATICAL COMPUTING; NON INFERIORITY MARGIN; NON INFERIORITY TEST; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICAL CONCEPTS; STATISTICAL SIGNIFICANCE; VARIANCE;

COHORT STUDIES; CROSS-OVER STUDIES; DATA INTERPRETATION, STATISTICAL; DRUG EVALUATION; HIV SEROPOSITIVITY; HUMANS; PLACEBOS; PROPORTIONAL HAZARDS MODELS;

EID: 39449121330     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.2988     Document Type: Article

References (6)

1. D'Agostino RB, Massaro JM, Sullivan L. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics. Statistics in Medicine 2003; 22:169-186.
2. Tsong Y, Wang S-J, Hung H-MJ. Statistical issues in objectives, designs and analysis of non-inferiority test active controlled clinical trials. Journal of Biopharmaceutical Statistics 2003; 13(1):29-41.
3. Holmgren EB. Establishing equivalence by showing that a pre-specified percentage of the effect of the active control over placebo is maintained. Journal of Biopharmaceutical Statistics 1999; 9(4):651-659.
4. Hasselblad V, Kong DF. Statistical methods for comparison to placebo in active-control trials. Drug Information Journal 2001; 35:435-449.
5. ICH Harmonized Triparties Guideline. Choice of Control Group and Related Issues in Clinical Trials: E19 [online]. Available from URL: http://www.ich.org/LOB/media/MEDIA486.pdf (Accessed 31 January 2007).
6. Tsong Y, Levenson M, Zhang JJ. Choice of δ-margin and the dependency of the non-inferiority tests. Journal of Biopharmaceutical Statistics 2007; 17(2):279-288.