Achieving Informed Consent in Clinical Trials

  • Arthur Schafer
Chapter

Abstract

The primary objective of clinical research is to discover which treatments are safe and effective. In order to demonstrate that a particular drug or surgical intervention is the best choice for patients with a particular disease or disability one must compare the alternatives. Thus, a new drug must be compared for efficacy and toxicity with the conventional treatment or with placebo. If the rate of cure, remission or palliation is significantly higher for those receiving the experimental treatment than for those who received the conventional treatment or placebo, then one may infer that the experimental treatment is preferable.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. [1]
    Hampton, J. (1983) The end of clinical freedom. Brit. Med. J., 287, 1237–1238CrossRefGoogle Scholar
  2. [2]
    Urbach, P. (1985) Randomization and the designs of experimentation. Phil. Sci., 52, 256–273CrossRefGoogle Scholar
  3. [3]
    Zelen, M. (1979) A new design for randomized clinical trials. New Engl. J. Med., 300, 1242–1245CrossRefGoogle Scholar
  4. [4]
    Zelen, M. (1982) Strategy and alternative randomized designs in cancer clinical trials. Cancer Treatment Reports 66, 1095–1100Google Scholar
  5. [5]
    Fisher, B. et al. (1985) Five-year result of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. New Engl. J. Med., 312, 665–673CrossRefGoogle Scholar
  6. [6]
    Marquis, D. (1986) An argument that all prerandomized clinical trials are unethical. J. Med. Phil., II, 367–383CrossRefGoogle Scholar
  7. [7]
    Palmer, M.J., O’Sullivan, B., Steele, R. and Mackillop, W.J. (1988) Empirical approach to ethical problems in oncology. Brit. J. Cancer (in press)Google Scholar
  8. [8]
    Schafer, A. (1982) The ethics of the randomized clinical trial. New Engl. J. Med., 307, 719–724CrossRefGoogle Scholar
  9. [9]
    Taylor, K., Margolese, R. and Soskolne, C. (1984) Physicians’ reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. New Engl. J. Med., 310, 1363–1367CrossRefGoogle Scholar
  10. [10]
    Levine, R. (1985) The use of placebos in randomized clinical trials. IRB: A Review of Human Subjects Research, 7 (2), 1–3CrossRefGoogle Scholar
  11. [11]
    Schafer, A. (1985) The randomized clinical trial: for whose benefit? IRB: A Review of Human Subjects Research, 7 (2), 4–7CrossRefGoogle Scholar
  12. [12]
    Marquis, D. (1983) Leaving therapy to chance: an impasse in the ethics of clinical trials. Hastings Centre Report, 13 (4), 40–47CrossRefGoogle Scholar
  13. [13]
    Applebaum, P., Roth, L. and Lidz, C. Jr (1983) Letter to the Editor. New Engl. J. Med., 308, 344Google Scholar
  14. [14]
    Lurie, N. and Shapiro, M. (1987) Is the pursuit of scientific truth always the greatest good? Ethical Issues in Health Care Research. Clin. Res., 517–520Google Scholar
  15. [15]
    Meisel, A. and Roth, L. (1983) Toward an informed discussion of informed consent: a review and critique of the empirical studies. Arizona Law Rev., 25, 265–346Google Scholar

Copyright information

© The Editor and Contributors 1989

Authors and Affiliations

  • Arthur Schafer

There are no affiliations available

Personalised recommendations