Three-sided hypothesis testing: Simultaneous testing of superiority, equivalence and inferiority

Statistics in Medicine

Volumn 29, Issue 20, 2010, Pages 2117-2125

  Goeman, Jelle J ^a   Solari, Aldo ^a,b   Stijnen, Theo ^a  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^b UNIVERSITY OF PADOVA   (Italy)

Author keywords

Clinical trials; Multiple testing; Non inferiority

Indexed keywords

ARTICLE; MATHEMATICAL ANALYSIS; PARAMETER; SIMULATION; THREE SIDED TESTING;

BIOSTATISTICS; CAROTID STENOSIS; CLINICAL TRIALS AS TOPIC; COLONIC NEOPLASMS; CONFIDENCE INTERVALS; DIABETES MELLITUS, TYPE 2; ENDARTERECTOMY, CAROTID; HUMANS; MODELS, STATISTICAL; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; STENTS; THERAPEUTIC EQUIVALENCY;

EID: 77956300037     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.4002     Document Type: Article

References (25)

1. ICH E9 Expert Working Group. Statistical principles for clinical trials: ICH harmonized tripartite guideline. Statistics in Medicine 1999;18:1905-1942.
2. Freedman LS. An analysis of the controversy over classical one-sided tests. Clinical Trials 2008; 5:635-640.
3. Kieser M. A confirmatory strategy for therapeutic equivalence trials. International Journal of Clinical Pharmacology and Therapeutics 1995; 33:388-390.
4. Morikawa T, Yoshida M. A useful testing strategy in phase III trials: combined test of superiority and test of equivalence. Journal of Biopharmaceutical Statistics 1995; 5:297-306.
5. Marcus R, Peritz E, Gabriel KR. On closed testing procedures with special reference to ordered analysis of variance. Biometrika 1976; 63:655-660.
6. Wiens BL. Something for nothing in noninferiority/superiority testing: a caution. Drug Information Journal 2001; 35:241-245.
7. Logan BR, Tamhane AC. Superiority inferences on individual endpoints following noninferiority testing in clinical trials. Biometrical Journal 2008; 50:693-703.
8. CHMP. Points to consider on switching between superiority and non-inferiority. British Journal of Clinical Pharmacology 2001; 52:223-228.
9. Ng TH. Simultaneous testing of noninferiority and superiority increases the false discovery rate. Journal of Biopharmaceutical Statistics 2007; 17:259-264.
10. Dunnett CW, Gent M. An alternative to the use of two-sided tests in clinical trials. Statistics in Medicine 1996; 15:1729-1738. (Pubitemid 26280303)
11. Bauer P, Kieser M. A unifying approach for confidence intervals and testing of equivalence and difference. Biometrika 1996; 83:934-937.
12. Kaiser HF. Directional statistical decisions. Psychological Review 1960; 67:160-167.
13. Shaffer JP. Multiplicity, directional (Type III) errors, and the null hypothesis. Psychological Methods 2002; 7:356-369.
14. Finner H, Strassburger K. The partitioning principle: a powerful tool in multiple decision theory. The Annals of Statistics 2002; 30:1194-1213.
15. Gould AL. 3-Decision rules for assessing superiority or equivalence. Proceedings of the ENAR Region of the International Biometric Society, Memphis, TN, 1997.
16. Koyama T, Westfall PH. Decision-theoretic views on simultaneous testing of superiority and noninferiority. Journal of Biopharmaceutical Statistics 2005; 15:943-955.
17. Sonnemann E. General solutions to multiple testing problems. Biometrical Journal 2008; 50:641-656.
18. Hirotsu C. A unifying approach to non-inferiority, equivalence and superiority tests via multiple decision processes. Pharmaceutical Statistics 2007; 6:193-203. (Pubitemid 47455259)
19. Shaffer JP. Modified sequentially rejective multiple test procedures. Journal of the American Statistical Association 1986; 81:826-831.
20. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Pharmacometrics 1987; 15:657-680.
21. Rice JA. Mathematical Statistics and Data Analysis (2nd edn). Duxbury: Belmont, 1995; 307.
22. Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J. TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. New England Journal of Medicine 2007; 356:775-789.
23. Colon Cancer Laparoscopic or Open Resection Study Group. Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Pøahlman L, Cuesta MA, Msika S, Morino M, Lacy A, Bonjer HJ. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomized clinical trial. Lancet Oncology 2009; 10:44-52.
24. Mas JL, Chatellier G, Beyssen B, Branchereau A, Moulin T, Becquemin JP, Larrue V, Lièvre M, Leys D, Bonneville JF, Watelet J, Pruvo JP, Albucher JF, Viguier A, Piquet P, Garnier P, Viader F, Touzé E, Giroud M, Hosseini H, Pillet JC, Favrole P, Neau JP, Ducrocq X. EVA-3S Investigators. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. New England Journal of Medicine 2006; 355:1660-1671. (Pubitemid 44583956)
25. Bretzel RG, Nuber U, Landgraf W, Owens DR, Bradley C, Linn T. Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomised controlled trial. Lancet 2008;371:1073-1084. (Pubitemid 351436611)