Research on the Therapy of Cancer

With Comment on IRB Review of Multiinstitutional Trials
  • Dale H. Cowan


Major advances in cancer therapy are attributable to clinical trials. There are two types of clinical trials: prospective and nonprospective trials. In prospective trials, subjects are allocated to two or more groups. One group serves as a “control” and receives whatever therapy is considered to be “standard” for the disease being studied. Standard therapy may be treatment with one or more drugs or, alternatively, no treatment. For example, the therapy given to patients in the control group of a clinical trial testing new treatments for metastatic carcinoma of the colon (colon cancer that has spread to distant organs) consists of the drug 5-fluorouracil. In contrast, standard therapy for the control group of patients with carcinoma of the colon that has not spread to distant organs is observation with no drug treatment. The other group(s) in the trial receive(s) the treatment(s) being tested. These may be a novel dose schedule of drugs known to have some effectiveness against the cancer being studied or a new drug not previously tested in the particular cancer.


Community Hospital Small Cell Carcinoma Federal Register Prospective Randomized Clinical Trial Ical Trial 
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Reference Notes

  1. 1.
    United States vs. Brandt, 2 Trials of War Criminals Before the Nuremberg Military Tribunals (The Medical Case), pp. 181-182, Military Tribunal I, 1947.Google Scholar
  2. 2.
    45 CFR Part 46, Section 46.111(a)(1)(i), Federal Register January 26, 1981; and Part 56, Section 56.111(a)(1)(i), Federal Register January 27, 1981.Google Scholar
  3. 3.
    Federal Register preamble to HHS final regulations, January 26, 1981, p. 8377; and Federal Register preamble to FDA final regulations, January 27, 1981, p. 8967.Google Scholar
  4. 4.
    45 CFR, Part 46, Section 46.111(a)(2), Federal Register January 26, 1981; and Part 56, Section 56.111(a)(2), Federal Register January 27, 1981.Google Scholar
  5. 5.
    45 CFR, Part 46, Section 46.116, Federal Register January 26, 1981.Google Scholar
  6. 6.
    45 CFR, Part 46, Section 46.116(b)(1)–(6), Federal Register January 26, 1981.Google Scholar
  7. 7.
    Research involving children, in: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, pp. 4-5, DHEW Publication No. (OS) 77-0004, Washington, D.C., 1977.Google Scholar
  8. 8.
    43 CFR, 31793, Section 46.404(a)(6) Federal Register 1978.Google Scholar
  9. 9.
    DHEW Secretary’s Task Force on the Compensation of Injured Research Subjects, 1977, DHEW Publication No. (OS) 77-003, Washington, D.C.Google Scholar
  10. 10.
    43 CFR, 51.559, Federal Register, 1978.Google Scholar
  11. 11.
    Section 46.116(a)(6), Federal Register January 26, 1981, and Section 50.25(a)(6), Federal Register January 27, 1981.Google Scholar


  1. Levine, R. J., and Lebacqz, K., 1979, Some ethical considerations in clinical trials, Clin. Pharm. Ther. 25:728–741.Google Scholar
  2. Beauchamp, T. L. and Childress, J. F., 1979, Principles of Biomedical Ethics, Oxford University Press, New York.Google Scholar
  3. WMA, 1964, Human experimentation: Code of ethics of the World Medical Association, Declaration of Helsinki, Brit. Med. J. 2:177.CrossRefGoogle Scholar

Copyright information

© Plenum Press, New York 1982

Authors and Affiliations

  • Dale H. Cowan
    • 1
    • 2
  1. 1.Division of Hematology/Oncology, Department of MedicineSt. Luke’s HospitalClevelandUSA
  2. 2.Department of MedicineCase Western Reserve UniversityClevelandUSA

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