Behavioral equipoise: A way to resolve ethical stalemates in clinical research

American Journal of Bioethics

Volumn 11, Issue 2, 2011, Pages 1-8

  Ubel, Peter A ^a   Silbergleit, Robert ^b  

^a DUKE UNIVERSITY   (United States)

^b UNIVERSITY OF MICHIGAN   (United States)

Author keywords

Decision making; Equipoise; Psychology; Research ethics

Indexed keywords

TISSUE PLASMINOGEN ACTIVATOR;

ARTICLE; BRAIN HEMORRHAGE; CHEMICALLY INDUCED DISORDER; CLINICAL PRACTICE; DECISION MAKING; EMERGENCY MEDICINE; EQUIPOISE; ETHICS; EVIDENCE BASED MEDICINE; EXPERT WITNESS; FIBRINOLYTIC THERAPY; HUMAN; METHODOLOGY; MULTICENTER STUDY (TOPIC); NATIONAL HEALTH ORGANIZATION; PHYSICIAN; PSYCHOLOGICAL ASPECT; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH ETHICS; STANDARD; STROKE; UNCERTAINTY; UNITED STATES;

CEREBRAL HEMORRHAGE; DECISION MAKING; EMERGENCY MEDICINE; ETHICS, RESEARCH; EVIDENCE-BASED MEDICINE; EXPERT TESTIMONY; HUMANS; MULTICENTER STUDIES AS TOPIC; NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE; PHYSICIAN'S PRACTICE PATTERNS; PHYSICIANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; STROKE; THERAPEUTIC EQUIPOISE; THROMBOLYTIC THERAPY; TISSUE PLASMINOGEN ACTIVATOR; UNCERTAINTY; UNITED STATES;

EID: 79951788665     PISSN: 15265161     EISSN: 15360075     Source Type: Journal    
DOI: 10.1080/15265161.2010.540061     Document Type: Article

References (29)

1. Abraham, E., P. F. Laterre, R. Garg, et al. 2005. Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death. New England Journal of Medicine 353(13): 1332–1341.
2. Adams, J. G., and C. D. Chisholm. 2003. The Society for Academic Emergency Medicine position on optimizing care of the stroke patient. Academic Emergency Medicine 10(7): 805.
3. American Academy of Emergency Medicine. 2002. Position statement of the American Academy of Emergency Medicine on the use of intravenous thrombolytic therapy in the treatment of stroke. Available at: http://www.aaem.org/positionstatements/thrombolytictherapy. php (accessed April 15, 2004).
4. AmericanCollege of Emergency Physicians. 2002. Use of intravenoust PA for the management of acute stroke in the emergency department. Available at: http://www.acep.org/practres.aspx?id = 29834 (accessed April 15, 2004).
5. Baron, J., and I. Ritov. 2004. Omission bias, individual differences, and normality. Organizational Behavior and Human Decision Processes 94: 74–85.
6. Bernard, G. R., J. L. Vincent, P. F. Laterre, et al. 2001. Efficacy and safety of recombinant human activated protein C for severe sepsis. New England Journal of Medicine 344(10): 699–709.
7. Brent, D. A. 2004. Antidepressants and pediatric depression—The risk of doing nothing. New England Journal of Medicine 351(16): 1598–1601.
8. Brown, D. L., W. G. Barsan, L. D. Lisabeth, et al. 2005. Survey of emergency physicians about recombinant tissue plasminogen activator for acute ischemic stroke. Annals of Emergency Medicine 46(1): 56–60.
9. Dellinger, R. P., M. M. Levy, J. M. Carlet, et al. 2004. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Critical Care Medicine 32(3): 858–873.
10. Eichacker, P. Q., C. Natanson, R. L. Danner, et al. 2006. Surviving sepsis—Practice guidelines, marketing campaigns, and Eli Lilly. New England Journal of Medicine 355(16): 1640–1642.
11. Finucane, M. L., A. Alhakami, P. Slovic, et al. 2000. The affect of heuristic judgments of risks and benefits. Journal of Behavioral Decision Making 13: 1–17.
12. Freedman, B. 1987. Equipoise and the ethics of clinical research. New England Journal of Medicine 317(3): 141–145.
13. Hellman, D. 2002. Evidence, belief, and action: The failure of equipoise to resolve the ethical tension in the randomized clinical trial. Journal of Law, Medicine, & Ethics 30: 375–380.
14. Johnston, S. C., L. H. Fung, L. A. Gillum, et al. 2001. Utilization of intravenous tissue-type plasminogen activator for ischemic stroke at academic medical centers: The influence of ethnicity editorial comment: It is time to implement stroke practice improvement programs and prevent the racial disparity in stroke care. Stroke 32: 1061–1068.
15. Kahneman, D., and A. Tversky. 1982. The psychology of preferences. Scientific American 246: 160–173.
16. Katzan, I. L., C. A. Sila, A. J. Furlan, et al. 2001. Community use of intravenous tissue plasminogen activator for acute stroke: Results of the Brain Matters Stroke Management Survey. Stroke 32(4): 861–865.
17. Lilford, R. J. 2003. Ethics of clinical trials froma bayesian and decision analytic perspective: Whose equipoise is it anyway? British Medical Journal 326: 980–981.
18. Lilly plans new clinical trial of xigris. 2007. PR Newswire. Available at: http://newsroom.lilly.com/ReleaseDetail.cfm? releaseid=231184
19. Loewenstein, G. F., E. U. Weber, C. K. Hsee, et al. 2001. Risk as feelings. Psychological Bulletin 127(2): 267–286.
20. Miller, F. G., and H. Brody. 2003. A critique of clinical equipoise: Therapeutic misconception in the ethics of clinical trials. Hastings Center Report 33(3): 19–28.
21. Nadel, S., B. Goldstein, M. D. Williams, et al. 2007. Drotrecogin alfa (activated) in children with severe sepsis: A multicentre phase III randomised controlled trial. Lancet 369(9564): 836–843.
22. Newman, T. B. 2004. A black-box warning for antidepressants in children? New England Journal of Medicine 351(16): 1595–1598.
23. Parrillo, J. E. 2005. Severe sepsis and therapywith activated protein C. New England Journal of Medicine 353(13): 1398–1400.
24. Psaty, B. M., and C. D. Furberg. 2005. COX-2 inhibitors—Lessons in drug safety. New England Journal of Medicine 352(11): 1133–1135.
25. Royall, R. 1997. Statistical evidence: A likelihood paradigm. London: Chapman and Hall.
26. National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. 1995. Tissue plasminogen activator for acute ischemic stroke. New England Journal of Medicine 333(24): 1581–1588.
27. Topol, E. J. 2005. Nesiritide—Not verified. New England Journal of Medicine 353(2): 113–116.
28. Ubel, P. A. 2009. Free market madness: Why human nature is at odds with economics—And why itmatters. Boston: Harvard Business Press.
29. Warren, H. S., A. F. Suffredini, P. Q. Eichacker, et al. 2002. Risks and benefits of activated protein C treatment for severe sepsis. New England Journal of Medicine 347(13): 1027–1030. 8