Time to end the non-inferiority complex?

Pharmaceutical Statistics

Volumn 10, Issue 5, 2011, Pages 393-394

  Julious, Steven A ^a  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; PLACEBO;

CLINICAL TRIAL (TOPIC); EDITORIAL; HUMAN; KIDNEY TRANSPLANTATION; MEDICAL RESEARCH; META ANALYSIS (TOPIC); OUTCOME ASSESSMENT; PRACTICE GUIDELINE; SAMPLE SIZE; SENSITIVITY ANALYSIS; STUDY DESIGN; SYSTEMATIC REVIEW (TOPIC);

CLINICAL TRIALS AS TOPIC; DRUG AND NARCOTIC CONTROL; HUMANS; INTERNATIONALITY; THERAPEUTIC EQUIVALENCY; TIME FACTORS;

EID: 80053565324     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.519     Document Type: Editorial

References (20)

1. International Conference on Harmonization. Choice of Control Group and Related Issues in Clinical Trials (ICH E-10), Food and Drug Administration, DHHS, 2001. Available at: (Date last accessed: 29th July 2011).
2. Rockhold F, Enas G,. 10 Years with ICH E10: choice of control groups. Pharmaceutical Statistics 2011; 10: 407-409.
3. CHMP. Guideline on the choice of non-inferiority margin. Doc CPMP/EWP/2158/99 January 2006.
4. FDA Guidance for Industry, Non-Inferiority Clinical Trials (draft), 2010.
5. Hummel J, Huitfeldt B,. The draft FDA guideline on non-inferiority clinical trials-a critical review from European pharmaceutical industry statisticians. Pharmaceutical Statistics 2011; 10: 414-419.
6. Wang SJ, Hung HMJ, Tsong Y,. Utility and pitfalls of some statistical methods in active controlled trials. Controlled Clinical Trials 2002; 23: 15-28. (Pubitemid 34164355)
7. Wang S-J, Blume J,. An evidential approach to non-inferiority clinical trials. Pharmaceutical Statistics 2011; 10: 440-447.
8. Snapinn SM,. Alternatives for discounting in the analysis of non-inferiority trials. Journal of Biopharmaceutical Statistics 2004; 14: 263-273. (Pubitemid 38715780)
9. Hasselblad V, Kong DF,. Statistical methods for comparison to placebo in activecontrol trials. Drug Information Journal 2001; 35: 435-449. (Pubitemid 32524896)
10. Julious SA,. The ABC of non-inferiority margin setting from indirect comparisons. Pharmaceutical Statistics 2011; 10: 448-453.
11. Julious SA, Wang SJ,. Issues with indirect comparisons in clinical trials particularly with respect to non-inferiority trials. DIJ 2008; 42 (6): 625-33.
12. Dann RS, Koch GG,. Methods for one-sided testing of the difference between proportions and sample size considerations related to non-inferiority clinical trials. Pharmaceutical Statistics 2008; 7: 130-141. (Pubitemid 351943641)
13. Julious SA,. Sample sizes for clinical trials. Chapman and Hall: London, 2009.
14. Julious SA, Owen R,. Sample size calculations for non-inferiority studies with binary outcomes. Statistical Methods in Medical Research. DOI: (10.1177/0962280210378945).
15. Snappin S, Jiang Q,. Indirect Comparisons in the Comparative Efficacy and Non-Inferiority Settings Pharmaceutical Statistics, 2011; 10: 420-426.
16. Cuffe RL, Mohamed K, Embleton A,. Adjusting for covariates in non-inferiority studies with margins defined as risk differences. Pharmaceutical Statistics 2011; 10: 461-466.
17. Witte S, Schmidli H, O'Hagan A, Racine-Poon A,. Designing a non-inferiority study in kidney transplantation: a case study. Pharmaceutical Statistics 2011; 10: 427-432.
18. Gerlinger C, Schmelter T,. Determining the non-inferiority margin for patient reported outcomes. Pharmaceutical Statistics 2011; 10: 410-413.
19. Burger HU, Beyer U, Abt M,. Issues in the assessment of non-inferiority: perspectives drawn from case studies. Pharmaceutical Statistics 2011; 10: 433-439.
20. Dane A,. Active controlled studies in antibiotic drug development. Pharmaceutical Statistics 2011; 10: 454-460.