Non-inferiority clinical trials: Practical issues and current regulatory perspective

Indian Journal of Pharmacology

Volumn 43, Issue 4, 2011, Pages 371-374

  Gupta, Sandeep K ^a  

^a NONE   (India)

Author keywords

Assay sensitivity; bio creep; clinical trials; non inferiority; sample size

Indexed keywords

ANTIBIOTIC AGENT; PLACEBO;

ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS; ACUTE BACTERIAL OTITIS MEDIA; ACUTE BACTERIAL SINUSITIS; ACUTE BACTERIAL SKIN INFECTION; ACUTE SINUSITIS; ANTIBIOTIC THERAPY; ARTICLE; BACTERIAL PNEUMONIA; BACTERIAL SINUSITIS; BACTERIAL SKIN DISEASE; BIO CREEP; CHRONIC BRONCHITIS; CLINICAL TRIAL (TOPIC); COMPARATIVE STUDY; DATA ANALYSIS; DRUG EFFICACY; DRUG INDICATION; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; HOSPITAL ACQUIRED PNEUMONIA; HUMAN; METHODOLOGY; NON INFERIORITY CLINICAL TRIAL; NULL HYPOTHESIS; OTITIS MEDIA; PRACTICE GUIDELINE; RESEARCH ETHICS; SAMPLE SIZE; SKIN STRUCTURE; STATISTICAL CONCEPTS; SYSTEMATIC ERROR; UNITED STATES; VENTILATOR ASSOCIATED PNEUMONIA;

EID: 80053231937     PISSN: 02537613     EISSN: 19983751     Source Type: Journal    
DOI: 10.4103/0253-7613.83103     Document Type: Article

References (33)

1. Kaul S, Diamond GA. Good enough: A primer on the analysis and interpretation of non-inferiority trials. Ann Intern Med 2006;145:62-9. (Pubitemid 46780603)
2. Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis 2008;66:150-4. (Pubitemid 351898384)
3. Greene CJ, Morland LA, Durkalski VL, Frueh BC. Noninferiority and equivalence designs: Issues and implications for mental health research. J Trauma Stress 2008;21:433-9.
4. Blackwelder WC. "Proving the null hypothesis" in clinical trials. Control Clin Trials 1982;3:345-53. (Pubitemid 13113168)
5. D'Agostino RB Sr, Massaro JM, Sullivan LM. Non-inferiority trials: Design concepts and issues - The encounters of academic consultants in statistics. Stat Med 2003;22:169-86. (Pubitemid 36163579)
6. Ricci S. What does 'non-inferior to' really mean? A clinician thinking out loud. Cerebrovasc Dis 2010;29:607-8.
7. Pocock SJ. The pros and cons of noninferiority trials. Fundam Clin Pharmacol 2003;17:483-90. (Pubitemid 36920651)
8. International Conference on Harmonisation. Guidance E10: Choice of Control Group and Related Issues in Clinical Trials, July 2000.
9. Pater C. Equivalence and noninferiority trials: Are they viable alternatives for registration of new drugs? (III). Curr Control Trials Cardiovasc Med 2004;5: 8.
10. Snapinn SM. Noninferiority trials. Curr Control Trials Cardiovasc Med 2000;1:19-21. (Pubitemid 32219869)
11. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry, Non-Inferiority Clinical Trials, March 2010.
12. James Hung HM, Wang SJ, Tsong Y, Lawrence J, O'Neil RT. Some fundamental issues with non-inferiority testing in active controlled trials. Stat Med 2003;22:213-25. (Pubitemid 36163582)
13. Committee for Proprietary Medicinal Products (CPMP). Guideline on the Choice of the Non-Inferiority Margin, July 2005.
14. Fleming TR. Current issues in non-inferiority trials. Stat Med 2008;27:317-32. (Pubitemid 351227869)
15. Laster LL, Johnson MF. Non-inferiority trials: The 'at least as good as' criterion. Stat Med 2003;22:187-200. (Pubitemid 36163580)
16. International Conference on Harmonisation. Guidance E9: Statistical Principles for Clinical Trials, February 1998.
17. Everson-Stewart S, Emerson SS. Bio-creep in non-inferiority clinical trials. Stat Med 2010;29:2769-80.
18. Committee for Proprietary Medicinal Products (CPMP). Points to Consider on Switching between Superiority and Non-Inferiority, July 2000.
19. Wiens BL, Zhao W. The role of intention to treat in analysis of non-inferiority studies. Clin Trials 2007;4:286-91. (Pubitemid 47400540)
20. Dasgupta A, Lawson KA, Wilson JP. Evaluating equivalence and non-inferiority trials. Am J Health Syst Pharm 2010;67:1337-43.
21. Le Henanff A, Giraudeau B, Baron G, Ravaud P. Quality of reporting of noninferiority and equivalence randomized trials. JAMA 2006;295:1147-51. (Pubitemid 43352344)
22. Blackwelder WC. Current issues in clinical equivalence trials. J Dent Res 2004;83:C113-5. (Pubitemid 44126052)
23. Zee BC. Planned equivalence or non-inferiority trials versus unplanned noninferiority claims: Are they equal? J Clin Oncol 2006;24:1026-8. (Pubitemid 46638796)
24. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ; CONSORT Group. Reporting of non-inferiority and equivalence randomized trials: An extension of the CONSORT statement. JAMA 2006;295:1152-60. (Pubitemid 43352345)
25. Murray GD. Switching between superiority and non-inferiority. Br J Clin Pharmacol 2001;52:219.
26. Garattini S, Bertele V. Non-inferiority trials are unethical because they disregard patients' interests. Lancet 2007;370:1875-7. (Pubitemid 350180009)
27. Chuang-Stein C, Beltangady M, Dunne M, Morrison B. The ethics of noninferiority trials. Lancet 2008;371:895-6;author reply 896-7.
28. Menten J, Boelaert M. The ethics of non-inferiority trials. Lancet 2008;371:896;author reply 896-7. (Pubitemid 351375268)
29. Nunn AJ, Meredith SK, Spigelman MK, Ginsberg AM, Gillespie SH. The ethics of non-inferiority trials. Lancet 2008;371:895;author reply 896-7. (Pubitemid 351375264)
30. Gandjour A. The ethics of non-inferiority trials. Lancet 2008;371:895;author reply 896-7. (Pubitemid 351375265)
31. Soliman EZ. The ethics of non-inferiority trials. Lancet 2008;371:895;author reply 896-7. (Pubitemid 351375266)
32. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry, Antibacterial Drug Products: Use of Non-inferiority Trials to Support Approval, November 2010.
33. Fleming TR, Powers JH. Issues in non-inferiority trials: The evidence in community-acquired pneumonia. Clin Infect Dis 2008;47:S108-20.