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.
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References
Hampton, J. (1983) The end of clinical freedom. Brit. Med. J., 287, 1237–1238
Urbach, P. (1985) Randomization and the designs of experimentation. Phil. Sci., 52, 256–273
Zelen, M. (1979) A new design for randomized clinical trials. New Engl. J. Med., 300, 1242–1245
Zelen, M. (1982) Strategy and alternative randomized designs in cancer clinical trials. Cancer Treatment Reports 66, 1095–1100
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, 665–673
Marquis, D. (1986) An argument that all prerandomized clinical trials are unethical. J. Med. Phil., II, 367–383
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)
Schafer, A. (1982) The ethics of the randomized clinical trial. New Engl. J. Med., 307, 719–724
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, 1363–1367
Levine, R. (1985) The use of placebos in randomized clinical trials. IRB: A Review of Human Subjects Research, 7 (2), 1–3
Schafer, A. (1985) The randomized clinical trial: for whose benefit? IRB: A Review of Human Subjects Research, 7 (2), 4–7
Marquis, D. (1983) Leaving therapy to chance: an impasse in the ethics of clinical trials. Hastings Centre Report, 13 (4), 40–47
Applebaum, P., Roth, L. and Lidz, C. Jr (1983) Letter to the Editor. New Engl. J. Med., 308, 344
Lurie, N. and Shapiro, M. (1987) Is the pursuit of scientific truth always the greatest good? Ethical Issues in Health Care Research. Clin. Res., 517–520
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, 265–346
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Schafer, A. (1989). Achieving Informed Consent in Clinical Trials. In: Stoll, B.A. (eds) Ethical Dilemmas in Cancer Care. Palgrave, London. https://doi.org/10.1007/978-1-349-10711-7_4
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DOI: https://doi.org/10.1007/978-1-349-10711-7_4
Publisher Name: Palgrave, London
Print ISBN: 978-1-349-10713-1
Online ISBN: 978-1-349-10711-7
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