How biased are indirect comparisons, particularly when comparisons are made over time in controlled trials?

Drug Information Journal

Volumn 42, Issue 6, 2008, Pages 625-633

  Julious, Steven A ^a   Wang, Sue Jane ^b  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

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

Author keywords

Clinical trials; Indirect comparisons; Noninferiority; Placebo creep

Indexed keywords

PAROXETINE; PLACEBO;

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; COMPARATIVE STUDY; CORRELATION ANALYSIS; DEPRESSION; HUMAN; INDIRECT COMPARISON; METHODOLOGY; PLACEBO EFFECT; PRIORITY JOURNAL; STATISTICS; TREATMENT RESPONSE;

EID: 57449091085     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150804200610     Document Type: Article

References (22)

1. Hasselblad V, Kong DF. Statistical methods for comparison to placebo in active-control trials. Drug Inf J. 2001;25:435-449.
2. Lim E, Ali Z, Ali A, et al. Indirect comparison meta-analysis of aspirin therapy after coronary surgery. Br Med J. 2003;327:1309-1313.
3. Song F, Altman DG, Glenny AM, Deeks JJ. Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses. Br Med J. 2003; 326:472.
4. Wang SJ, Hung HMJ, Tsong Y. Non-inferiority analysis in active controlled trials. Encyclopaedia of Biopharmaceutical Statistics, 2nd ed. New York: Marcel Dekker; 2003: 674-677.
5. D'Agostino RB, Massaro J, Sullivan LM. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics. Stat Med. 2003;22:169-186.
6. Wang SJ, Hung HMJ, Tsong Y. Utility and pitfalls of some statistical methods in active controlled trials. Control Clin Trials. 2002;23:15-28.
7. Snapinn SM. Alternatives for discounting in the analysis of non-inferiority trials. J Biopharm Stat. 2004;14:263-273.
8. Bech P. Meta analysis of placebo controlled trials with mirtazipine using core items of the Hamilton depression scale as evidence of pure anti-depressive effect in the short term treatment of major depression. Int J Neuropsychopharmacol. 2001;4:337-345.
9. Furukawa T, McGuire H, Barbui C. Low dosage tricyclic antidepressants for depression. Cochrane Database. 2003.
10. Wilson K, Motram P, Svanranthan P. Nightingale A. Antidepressants versus placebo for the depressed elderly. Cochrane Database. 2003.
11. Hazell P, O'Connel D, Heathcote D, Henry D. Tricyclic drugs for depression in children and adolescents. Cochrane Database. 2003.
12. Walsh BT, Sneidman SN, Sysko R, Gould M. Placebo response in studies of major depression, variable, substantial and growing. JAMA. 2002;14: 1840-1847.
13. McClung C, Quessy S, Julious S, Segretti A, Blum D. Placebo response rates in geographical location in COX-2 inhibitor trials of rheumatoid arthritis (RA) and osteoarthritis (OA). Paper presented at American College of Rheumatology Conference, San Antonio, 2004.
14. CHMP. Points to consider on switching between superiority and non-inferiority. Doc CPMP/EWP/482/99. 2000. Available at: http://www.tga.gov.au/docs/pdf/euguide/ewp/048299en.pdf. Accessed April 14, 2008.
15. ICH E10. Choice of control group in clinical trials. 2000. Available at: http://www.ich.org/LOB/media/MEDIA486.pdf. Accessed April 14, 2008.
16. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. Br Med J. 1996;313:36-39.
17. Hung HMJ, Wang SJ, Lawrence J, O'Neil RT. Some fundamental issues with non-inferiority testing in active controlled trials. Stat Med. 2003;22: 213-225.
18. Wiens BL. Choosing an equivalence limit for non-inferiority and/or equivalence studies. Control Clin Trials. 2002;23:2-14.
19. CHMP. Guideline on the choice of non-inferiority margin. Doc CPMP/EWP/ 2158/99. 2005. Available at: http://www.emea.europa.eu/pdfs/human/ewp/ 215899en.pdf. Accessed April 14, 2008.
20. Julious SA. Tutorial in biostatistics: sample sizes for clinical trials with normal data. Stat Med. 2004;23:1921-1986.
21. Wang SJ, Hung HMJ. TACT method for non-inferiority testing in active controlled trials. Stat Med. 2003;22:227-238.
22. Datta S, Halloran ME, Longini IM. Augmented HIV vaccine trial design for estimating reduction in infectiousness and protective efficacy. Stat Med. 1998;17:185-200.