Prevalence and factors associated with use of placebo control groups in randomized controlled trials in psoriasis: A cross-sectional study

Journal of the American Academy of Dermatology

Volumn 55, Issue 5, 2006, Pages 814-822

  Katz, Kenneth A ^a   Karlawish, Jason H ^b,d   Chiang, David S ^c   Bognet, Rachel A ^f   Propert, Katherine J ^c,e   Margolis, David J ^a,e  

^a Departments of Dermatology   (United States)

^b Medicine

^c Biostatistics ^*

^d Centers for Bioethics

^e UNIVERSITY OF PENNSYLVANIA   (United States)

^f THOMAS JEFFERSON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; COCHRANE LIBRARY; CONFIDENCE INTERVAL; DRUG INDUSTRY; FINANCIAL MANAGEMENT; LOGISTIC REGRESSION ANALYSIS; MULTIVARIATE ANALYSIS; PRIORITY JOURNAL; PSORIASIS; RESEARCH ETHICS; UNITED STATES;

CROSS-SECTIONAL STUDIES; DRUG INDUSTRY; HUMANS; PLACEBOS; PSORIASIS; RANDOMIZED CONTROLLED TRIALS; RESEARCH SUPPORT; UNITED STATES;

EID: 33750045210     PISSN: 01909622     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jaad.2006.07.005     Document Type: Article

References (50)

1. Oxford English Dictionary. 2nd ed. (1989), Oxford University Press, Oxford (UK). http://dictionary.oed.com/ Accessed March 22, 2006
2. Rothman K.J., and Michels K.B. The continuing unethical use of placebo controls. N Engl J Med 331 (1994) 394-398
3. Ellenberg S.S., and Temple R. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: practical issues and specific cases. Ann Intern Med 133 (2000) 464-470
4. Temple R., and Ellenberg S.S. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Ann Intern Med 133 (2000) 455-463
5. Emanuel E.J., and Miller F.G. The ethics of placebo-controlled trials-a middle ground. N Engl J Med 345 (2001) 915-919
6. Michels K.B., and Rothman K.J. Update on unethical use of placebos in randomised trials. Bioethics 17 (2003) 188-204
7. Levine R.J. The need to revise the Declaration of Helsinki. N Engl J Med 341 (1999) 531-534
8. Rothman K.J. Placebo mania. BMJ 313 (1996) 3-4
9. Weijer C., Dickens B., and Meslin E.M. Bioethics for clinicians: 10. Research ethics. CMAJ 156 (1997) 1153-1157
10. Lewis J.A., Jonsson B., Kreutz G., Sampaio C., and van Zwieten-Boot B. Placebo-controlled trials and the Declaration of Helsinki. Lancet 359 (2002) 1337-1340
11. Saunders J., and Wainwright P. Risk, Helsinki 2000 and the use of placebo in medical research. Clin Med 3 (2003) 435-439
12. Freedman B., Glass K.C., and Weijer C. Placebo orthodoxy in clinical research. II: Ethical, legal, and regulatory myths. J Law Med Ethics 24 (1996) 252-259
13. Freedman B., Weijer C., and Glass K.C. Placebo orthodoxy in clinical research. I: Empirical and methodological myths. J Law Med Ethics 24 (1996) 243-251
14. Miller F.G., and Brody H. What makes placebo-controlled trials unethical?. Am J Bioeth 2 (2002) 3-9
15. Angell M. The ethics of clinical research in the Third World. N Engl J Med 337 (1997) 847-849
16. Lurie P., and Wolfe S.M. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med 337 (1997) 853-856
17. Varmus H., and Satcher D. Ethical complexities of conducting research in developing countries. N Engl J Med 337 (1997) 1003-1005
18. World Medical Association. Declaration of Helsinki. Ferney-Voltaire (France): WMA; 2004 Sep 10. Available from: http://www.wma.net/e/policy/pdf/17c.pdf. Accessed March 22, 2006.
19. Carlson R.V., Boyd K.M., and Webb D.J. The revision of the Declaration of Helsinki: past, present and future. Br J Clin Pharmacol 57 (2004) 695-713
20. Miller F.G., and Shorr A.F. Unnecessary use of placebo controls: the case of asthma clinical trials. Arch Intern Med 162 (2002) 1673-1677
21. Halpern S.D., and Karlawish J.H. Placebo-controlled trials are unethical in clinical hypertension research. Arch Intern Med 160 (2000) 3167-3169
22. Al-Khatib S.M., Califf R.M., Hasselblad V., Alexander J.H., McCrory D.C., and Sugarman J. Medicine. Placebo-controls in short-term clinical trials of hypertension. Science 292 (2001) 2013-2015
23. Neimann A.L., Porter S.B., and Gelfand J.M. The epidemiology of psoriasis. Expert Rev Dermatol 1 (2006) 63-75
24. Rapp S.R., Feldman S.R., Exum M.L., Fleischer Jr. A.B., and Reboussin D.M. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol 41 (1999) 401-407
25. Javitz H.S., Ward M.M., Farber E., Nail L., and Vallow S.G. The direct cost of care for psoriasis and psoriatic arthritis in the United States. J Am Acad Dermatol 46 (2002) 850-860
26. Callen J.P., Krueger G.G., Lebwohl M., McBurney E.I., Mease P., Menter A., et al. AAD consensus statement on psoriasis therapies. J Am Acad Dermatol 49 (2003) 897-899
27. Sterry W., Barker J., Boehncke W.H., Bos J.D., Chimenti S., Christophers E., et al. Biological therapies in the systemic management of psoriasis: International Consensus Conference. Br J Dermatol 151 Suppl 69 (2004) 3-17
28. Troy T., Biologic approved for psoriasis. Dermatol Times 2004 Jun 1. Available from: =http://www.dermatologytimes.com/dermatologytimes/article/articleDetail. jsp?id=102174. Accessed March 22, 2006 Mar.
29. Schleyer V., Landthaler M., and Szeimies R.M. Novel pharmacological approaches in the treatment of psoriasis. J Eur Acad Dermatol Venereol 19 (2005) 1-20
30. Nickoloff B.J., and Stevens S.R. What have we learned in dermatology from the biologic therapies?. J Am Acad Dermatol 54 Suppl (2006) S143-S151
31. Sauder D.N., and Mamelak A.J. Understanding the new clinical landscape for psoriasis: a comparative review of biologics. J Cutan Med Surg 8 (2004) 205-212
32. Ellis C.N., and Krueger G.G. Treatment of chronic plaque psoriasis by selective targeting of memory effector T lymphocytes. N Engl J Med 345 (2001) 248-255
33. Rosenblatt M. Is it ethical to conduct placebo-controlled clinical trials in the development of new agents for osteoporosis? An industry perspective. J Bone Miner Res 18 (2003) 1142-1145
34. Temple R. Problems in interpreting active control equivalence trials. Account Res 4 (1996) 267-275
35. US 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 - E 10 Choice of Control Group and Related Issues in Clinical Trials. Rockville (MD): FDA; 2001 May. Available from: http://www.fda.gov/cder/guidance/4155fnl.pdf. Accessed March 22, 2006.
36. Collier J. Confusion over use of placebos in clinical trials. BMJ 311 (1995) 821-822
37. The Cochrane Library [database on the Internet]. Hoboken (NJ): John Wiley & Sons; Available from: http://www.mrw.interscience.wiley.com/cochrane/cochrane_clcentral_articl es_fs.html. Accessed December 20, 2005.
38. Appendix A: Criteria for RCTs and CCTs. In: Training Manual for Handsearchers. Baltimore (MD): US Cochrane Center; 2002 Dec 13; p. A-1-A-6. Available from: http://www.cochrane.org/resources/hsearch.htm. Accessed March 29, 2006.
39. Maldonado G., and Greenland S. Simulation study of confounder-selection strategies. Am J Epidemiol 138 (1993) 923-936
40. Mickey R.M., and Greenland S. The impact of confounder selection criteria on effect estimation. Am J Epidemiol 129 (1989) 125-137
41. Sinclair J.C., and Bracken M.B. Clinically useful measures of effect in binary analyses of randomized trials. J Clin Epidemiol 47 (1994) 881-889
42. International Committee on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use [homepage on the Internet]. Geneva: ICH. E10: Choice of Control Group and Related Issues in Clinical Trials; [about 1 screen]. Available from: http://www.ich.org/cache/compo/276-254-1.html. Accessed April 3, 2006.
43. Committee for Medicinal Products for Human Use (CHMP); European Medicines Agency. Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. Available at: http://www.emea.eu.int/pdfs/human/ewp/043804en.pdf. Accessed August 11, 2006.
44. Department of Health and Aging: Therapeutic Goods Administration; Australian Government. EU guideline- as adopted in Australia by the TGA - with amendment. Available at: http://www.tga.gov.au/docs/pdf/euguide/ewp/245402en.pdf. Accessed August 14, 2006.
45. Biogen Idec Inc. Amevive (alefacept) package insert. I63007-5 (2005), Biogen Idec, Cambridge (MA)
46. Immunex Corp. Enbrel (etanercept) package insert. 3XXXXXX-v4 (2006), Immunex, Thousand Oaks (CA) Mar 8
47. Genentech, Inc. Raptiva (efalizumab) package insert. LQ0198 7711100 (2005), Genentech, South San Francisco (CA)
48. Heydendael V.M., Spuls P.I., Opmeer B.C., de Borgie C.A., Reitsma J.B., Goldschmidt W.F., et al. Methotrexate versus cyclosporine in moderate-to-severe chronic plaque psoriasis. N Engl J Med 349 (2003) 658-665
49. Emanuel E.J., Wendler D., and Grady C. What makes clinical research ethical?. JAMA 283 (2000) 2701-2711
50. William C. Hamlet, Plaintiff, v. Genentech, Inc., et al. Complaint and demand for jury trial. In the General Court of Justice, Superior Court Division, 03 CVS 1161, Orange County (NC); 2003 July. Available from: http://www.sskrplaw.com/gene/hamletcomplaint.pdf. Accessed March 30, 2006.