Can keeping clinical trial participants blind to their study treatment adversely affect subsequent care?

Contemporary Clinical Trials

Volumn 26, Issue 3, 2005, Pages 290-299

  Blader, Joseph C ^a,b,c  

^a STONY BROOK UNIVERSITY   (United States)

^b ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^c STONY BROOK UNIVERSITY   (United States)

Author keywords

Clinical trials; Double blind method; Ethical concerns

Indexed keywords

ANTICONVULSIVE AGENT; ANXIOLYTIC AGENT; MOOD STABILIZER; NEUROLEPTIC AGENT; PLACEBO;

ANXIETY DISORDER; AWARENESS; CLINICAL RESEARCH; CLINICAL TRIAL; HEALTH CARE; HUMAN; MEDICAL ETHICS; METHODOLOGY; OUTCOMES RESEARCH; REVIEW; RISK ASSESSMENT; SCHIZOAFFECTIVE PSYCHOSIS; SCHIZOPHRENIA; SYMPTOM; VALIDATION PROCESS;

EID: 19444372689     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2005.01.003     Document Type: Article

References (28)

1. K.F. Schulz, I. Chalmers, R.J. Hayes, and D.G. Altman Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials JAMA 273 1995 408 412
2. K. Getz, and D. Borfitz Informed consent: a guide to the risks and benefits of volunteering for clinical trials 2002 Thomson CenterWatch Boston
3. V. Kafantaris, D. Coletti, and R. Dicker Lithium treatment of acute mania in adolescents: a placebo-controlled discontinuation study J. Am. Acad. Child. Adolesc. Psychiatry 43 2004 984 993
4. A. Hrobjartsson, and P.C. Gotzsche Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment N. Engl. J. Med. 344 2001 1594 1602
5. S. Al-Khatib, R.M. Califf, and V. Hasselblad Placebo-controls in short-term clinical trials of hypertension Science 292 2003 2013 2015
6. J.A. Turner, M.P. Jensen, C.A. Warms, and D.D. Cardenas Blinding effectiveness and association of pretreatment expectations with pain improvement in a double-blind randomized controlled trial Pain 99 2002 91 99
7. A. Bystritsky, and S.V. Waikar Inert placebo versus active medication. Patient blindability in clinical pharmacological trials J. Nerv. Ment. Dis. 182 1994 485 487
8. M. Moscucci, L. Byrne, M. Weintraub, and C. Cox Blinding, unblinding, and the placebo effect: an analysis of patients' guesses of treatment assignment in a double-blind clinical trial Clin. Pharmacol. Ther. 41 1987 259 265
9. J. Howard, A.S. Whittemore, J.J. Hoover, and M. Panos How blind was the patient blind in AMIS? Clin. Pharmacol. Ther. 32 1982 543 553
10. T.J. Cleophas Clinical trials: specific problems associated with the use of a placebo-control group J. Mol. Med. 73 1995 421 424
11. R. Temple, and S.E. Ellenberg 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
12. L. Bienenfeld, W. Frishman, and S.P. Glasser The placebo effect in cardiovascular disease Am. Heart J. 132 1996 1207 1221
13. P.I. Clark, and P.E. Leaverton Scientific and ethical issues in the use of placebo controls in clinical trials Annu. Rev. Public Health 15 1994 19 38
14. R.J. Levine Ethics of clinical trials: do they help the patient? Cancer 72 1993 2805 2810
15. F. Garcia-Alonso, E. Guallar, O.M. Bakke, and X. Carne Use and abuse of placebo in phase III trials Eur. J. Clin. Pharmacol. 54 1998 101 105
16. P. Wainwright Consent to open label extension studies: some ethical issues J. Med. Ethics 28 2002 373 376
17. L.C. Swartzman, and J. Burkell Expectations and the placebo effect in clinical drug trials: why we should not turn a blind eye to unblinding, and other cautionary notes Clin. Pharmacol. Ther. 64 1998 1 7
18. G. Annas Questing for grails: duplicity, betrayal and self-deception in postmodern medical research J. Contemp. Health Law Policy 12 1996 297 324
19. S.D. Halpern Evaluating preference effects in partially unblinded, randomized clinical trials J. Clin. Epidemiol. 56 2003 109 115
20. M.A. Flaten, T. Simonsen, and H. Olsen Drug-related information generates placebo and nocebo responses that modify the drug response Psychosom. Med. 61 1999 250 255
21. H. Spiegel Nocebo: the power of suggestibility Prev. Med. 26 1997 616 621
22. R.A. Hahn The nocebo phenomenon: concept, evidence, and implications for public health Prev. Med. 26 1997 607 611
23. D.A. Braunholtz, S.J.L. Edwards, and R.J. Lilford Are randomized clinical trials good for us (in the short term)? Evidence of a "trial effect" J. Clin. Epidemiol. 54 2001 217 224
24. World Medical Association Declaration of Helsinki, ethical principles for medical research involving human subjects 1964 Ferney-Voltaire France
25. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use ICH harmonised tripartite guidelines, E6: guideline for good clinical practice Fed. Regist. 62 1996 25691 25709
26. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research The Belmont report, ethical principles and guidelines for the protection of human subjects of research 1979 (April 18) U.S. Dept. of Health, Education, and Welfare Washington (DC)
27. U.S. Department of Health and Human Services Common rule, 45 CFR 46. Federal policy for the protection of human subjects: notices and rules Fed. Regist. 56 1991 28003 28032
28. T.J. Cleophas, and P. Tavenier Clinical trials in chronic diseases J. Clin. Pharmacol. 35 1995 594 598