Simultaneous testing of noninferiority and superiority increases the false discovery rate

Journal of Biopharmaceutical Statistics

Volumn 17, Issue 2, 2007, Pages 259-264

  Ng, Tie Hua ^a  

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

Author keywords

Active control; Bayesian; False discovery rate; Multiplicity adjustment; Noninferiority; Simultaneous testing

Indexed keywords

ARTICLE; BAYES THEOREM; CLINICAL RESEARCH; DRUG INDUSTRY; FALSE NEGATIVE RESULT; FALSE POSITIVE RESULT; NULL HYPOTHESIS; PRIORITY JOURNAL; STATISTICAL ANALYSIS; STATISTICAL CONCEPTS; STATISTICAL DISTRIBUTION;

BAYES THEOREM; CONFIDENCE INTERVALS; CONTROLLED CLINICAL TRIALS; HUMANS; MODELS, STATISTICAL; RESEARCH DESIGN;

EID: 33947259037     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400601177459     Document Type: Article

References (9)

1. Benjamini, Y., Hochberg, Y. (1995). Controlling the false discovery rate: a practical and powerful approach to multiple testing. Journal of the Royal Statistical Society, Series B: Methodological 57:289-300.
2. Dunnett, C. W., Gent, M. (1976). An alternative to the use of two-sided tests in clinical trials. Statistics in Medicine 15:1729-1738.
3. European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products (CPMP). (2000). Points to consider on switching between superiority and noninferiority, www.emea.europa.eu/pdfs/human/ewp/ 048299.en.pdf (Accessed: January 2007)
4. Ioannidis, J. P. A. (2005). Why most published research findings are false. PLoS Medicine 2(8):e124.
5. Koyama, T., Westfall, P. H. (2005). Decision-theoretic views on simultaneous testing of superiority and noninferiority. Journal of Biopharmaceutical Statistics 15:943-955.
6. Morikawa, T., Yoshida, M. (1995). A useful testing strategy in Phase III trials: Combined test of superiority and test of equivalence. Journal of Biopharmaceutical Statistics 5:297-306.
7. Ng, T.-H. (2003). Issues of simultaneous tests for noninferiority and superiority and superiority (with discussion). Journal of Biopharmaceutical Statistics 13:629-662.
8. Phillips, A., Ebbutt, A., France, L., Morgan, D. (2000). The international conference on harmonization guideline statistical principles for clinical trials: issues in applying the guideline in practice. Drug Information Journal 34:337-348.
9. Soric, B. (1989). Statistical discoveries and effect size estimation. Journal of the American Statistical Association 84:608-610.