Hostname: page-component-cd9895bd7-8ctnn Total loading time: 0 Render date: 2024-12-26T05:46:53.330Z Has data issue: false hasContentIssue false
  • English
  • Français

Community Equipoise and the Architecture of Clinical Research

Published online by Cambridge University Press:  29 July 2009

Jason H. T. Karlawish  and
John Lantos
Jason H. T. Karlawish
Affiliation:
is Fellow of Geriatric Medicine, Section of General Internal Medicine, The University of Chicago.
John Lantos
Affiliation:
is the associate director of the Center for Clinical Medical Ethics, the Pritzker School of Medicine, Department of Pediatrics, The University of Chicago.
Get access Rights & Permissions [Opens in a new window]

Extract

Equipoise is an essential condition to justify a clinical trial. The term, describes a state of uncertainty: the data suggest but do not prove a drug's safety and efficacy The only way to resolve this uncertainty is further study In many cases, a clinical trial seems to be the most efficient way to prove safety and efficacy Equipoise is therefore not an esoteric philosophic construct applied to research ethics. Rather, since it is vital for the justification of clinical trials, it is part of how society regulates medical progress. Where there is equipoise, drug design and development proceeds according to Food and Drug Administration (FDA) and Health and Human Services (HHS) regulations. When that equipoise ends, a drug is either not approved or becomes standard care.

Type
Special Section: Expanding the Boundaries of Bioethics
Information
Cambridge Quarterly of Healthcare Ethics , Volume 6 , Issue 4 , Fall 1997 , pp. 385 - 396
Copyright
Copyright © Cambridge University Press 1997

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1. Taylor, KM, Margolese, RG, Soskolne, CL. Physicians’ reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. New England Journal of Medicine 1984;310:1363–7.CrossRefGoogle ScholarPubMed

2. Freedman, B. Equipoise and the ethics of clinical research. New England Journal of Medicine 1987;317:141–5.CrossRefGoogle ScholarPubMed

3. See note 2, Freedman 1987:144.

4. Fried, C. Medical Experimentation: Personal Integrity and Social Policy. Amsterdam: North Holland Publishing Company, 1974:149–50.Google Scholar

5. Kolata, G. Women rejecting trials for testing cancer therapy. New York Times 1995; 15 Feb: A1,B7.Google Scholar

6. See note 2, Freedman 1987.

7. Edgar, H, Rothman, DJ. New rules for new drugs: the challenge of AIDS to the regulatory process. The Milbank Quarterly 1990;68(S1):111–42.CrossRefGoogle ScholarPubMed

8. Epstein, S. The construction of lay expertise: AIDS activism and the forging of credibility in the reform of clinical trials. Science, Technology & Human Values 1995;20:408–37.CrossRefGoogle ScholarPubMed

9. Brody, BA. Troubling ethical issues in the approval of new drugs. Ethical Issues in Drug Testing, Approval, and Pricing: The Clot-Dissolving Drugs. New York: Oxford University Press, 1995:158–209.Google Scholar

10. Department of Health and Human Services. Food and Drug Administration. Protection of human subjects: informed consent; proposed rule. Federal Register 1995;60:49085–103.Google Scholar

11. Department of Health and Human Services. Food and Drug Administration. Protection of human subjects; informed consent and waiver of informed consent requirements in certain emergency research; final rules. Federal Register 1996;61:51497–531.Google Scholar

12. Karlawish, JHT, Hall, JB. The controversy over emergency research: a review of the issues and suggestions for a resolution. American Journal of Respiratory and Critical Care Medicine 1996;153:499–506.CrossRefGoogle ScholarPubMed

13. Brock, DW. The ideal of shared decision making between physicians and patients. In: Life and Death: Philosophical Essays in Biomedical Ethics. Cambridge: Cambridge University Press, 1993: 55–79.CrossRefGoogle Scholar

14. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research: 1980–1983. Making Health Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Washington (DC): Government Printing Office, 1982; vol 1:15–36.Google Scholar

15. Brown, P. Naming and framing: the social construction of diagnosis and illness. Journal of Health and Social Behavior 1995;Extra Issue:34–52.CrossRefGoogle ScholarPubMed

16. alt.support.cancer. 28 March 1995.

17. See note 8, Epstein, 1995.Google Scholar

18. See note 9, Brody, 1995.Google Scholar

19. Department of Health and Human Services. Food and Drug Administration. 21 CFR part 312. Investigational new drug, antibiotic, and biological drug product regulations; treatment use and sale. Federal Register 1987;52:19466–77.Google Scholar

20. Department of Health and Human Services. Public Health Service. Expanded availability of investigational new drugs through a parallel track mechanism for people with AIDS and other HIV-related disease. Federal Register 1992;57:13250–9.Google Scholar

21. Department of Health and Human Services. Food and Drug Administration. 21 CFR parts 312 and 314. Investigational new drug, antibiotic, and biological drug product regulations; procedures for drugs intended to treat life-threatening and severely debilitating illnesses. Federal Register 1988;53:41516–24.Google Scholar

22. Department of Health and Human Services. Food and Drug Administration. 21 CFR parts 314 and 601; New drug, antibiotic, and biological drug product regulations; accelerated approval; final rule. Federal Register 1992;57:58942–60.Google Scholar

23. See note 9, Brody 1995.

24. See note 21, Department of Health and Human Services 1988:41520.Google Scholar

25. See note 21, Department of Health and Human Services 1988:41518.Google Scholar

26. See note 10, Department of Health and Human Services 1995.Google Scholar

27. See note 11, Department of Health and Human Services 1996.Google Scholar

28. See note 12, Karlawish, Hall 1996.Google Scholar

29. Pendergast, M. New FDA guidelines on emergency and acute care research. Plenary address at “IRB's: Encountering the Special Problems of This Decade” Boston, Massachusetts, 19 10 1995.Google Scholar

30. Ellis, G. Perspectives from OPRR. Plenary address at “IRB's: Encountering the Special Problems of This Decade.” Boston, Massachusetts, 19 10 1995.Google Scholar

31. See note 7, Edgar, , Rothman, 1990.Google Scholar

32. Freedman, B. Scientific value and validity as ethical requirements for research: a proposed explanation. IRB: Review of Human Subjects Research 1987;9(6):7–10.CrossRefGoogle Scholar

33. See note 13, Brock, 1993Google Scholar.

34. See note 14, President's Commission 1982.Google Scholar

35. See note 13, Brock, 1993.Google Scholar

36. Veatch, RM. Abandoning informed consent. Hastings Center Report 1995;25(2):5–12.CrossRefGoogle ScholarPubMed

37. See note 36, Veatch, 1995.Google Scholar

38. See note 13, Brock, 1993.Google Scholar

39. See note 14, President's Commission 1982.Google Scholar

40. Rawls, J. A Theory of Justice. Cambridge (MA): Harvard University Press, 1970:20.Google Scholar

41. See note 2, Freedman, 1987:144.Google Scholar

42. See note 40, Rawls, 1970.Google Scholar

43. Ingelfinger, FJ. Informed (but uneducated) consent. New England Journal of Medicine 1972;287:465–6.CrossRefGoogle ScholarPubMed

44. Demy, NJ. Informed opinion about informed consent (letter). JAMA 1971;217:696–7.CrossRefGoogle Scholar

45. See note 4, Fried, 1974.Google Scholar

46. See note 2, Freedman, 1987:144.Google Scholar

47. Kuhn, TS. The Structure of Scientific Revolutions, 2nd ed.Chicago: The University of Chicago Press, 1970.Google Scholar

48. See note 47, Kuhn, 1970:19.Google Scholar

49. See note 15, Brown, 1995.Google Scholar

50. See note 8, Epstein, 1995.Google Scholar

51. These three points are, of course, only a limited treatment of these issues. In a subsequent paper, we plan to address them in greater detail.