Skip to main content
SpringerLink
Log in

Ethical Issues and Clinical Trials

  • Leading Article
  • Published:
Drugs Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  • Beecher H. Ethics and clinical research. New England Journal of Medicine 274: 1354–1360, 1966

    Article  PubMed  CAS  Google Scholar 

  • Cardiac Arrhythmia Suppression Trial Investigators. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. New England Journal of Medicine 321: 406–412, 1989

    Article  Google Scholar 

  • Coronary Drug Project Research Group. The Coronary Drug Project: initial findings leading to modification of its research protocol. Journal of the American Medical Association 214: 1303–1313, 1970

    Article  Google Scholar 

  • Coronary Drug Project Research Group. The Coronary Drug Project: findings leading to further modifications of its protocol with respect to dextrothyroxine. Journal of the American Medical Association 220: 996–1008, 1972

    Article  Google Scholar 

  • 21 Code of Federal Regulations (US), Part 56, 1992

  • 45 Code of Federal Regulations (US), Part 46, 1991

  • Curran W. The Tuskegee syphilis study. New England Journal of Medicine 289: 730–731, 1973

    Article  PubMed  CAS  Google Scholar 

  • EC-IC Bypass Study Group. Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke: results of an international trial. New England Journal of Medicine 313: 1191–1200, 1985

    Article  Google Scholar 

  • Farrow G. Ethics of funding clinical investigation. Canadian Journal of Surgery 32: 320, 1989

    CAS  Google Scholar 

  • Fincke M. Arzneimittelprufung: Strafbare Versuchsmethoden. (The testing of medicines: punishable experimental methods). Muller Juristischer Verlag, Heidelberg/Karlsruhe, 1977

  • Fisher B, Bauer M, Margolese R, Poisson R, Pilch Y, et al. Five year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. New England Journal of Medicine 312: 665–673, 1985

    Article  PubMed  CAS  Google Scholar 

  • Freedman B. Equipoise and the ethics of clinical research. New England Journal of Medicine 317: 141–145, 1987

    Article  PubMed  CAS  Google Scholar 

  • Hellman S. Editorial: randomized clinical trials and the doctor-patient relationship. An ethical dilemma. Cancer Clinical Trials 2: 189–193, 1979

    Google Scholar 

  • Hellman S, Hellman D. Of mice but not men: problems of the randomized clinical trial. New England Journal of Medicine 324: 1585–1589, 1991

    Article  PubMed  CAS  Google Scholar 

  • Jellinek M. IRBs and pharmaceutical company funding of research. IRB 4: 9, 1982

    Article  PubMed  Google Scholar 

  • Katz J. Experimentation with human beings, pp. 9–65, Russell Sage Foundation, New York, 1972

    Google Scholar 

  • Krugman S, Giles J, Hammond J. Infectious hepatitis: evidence for two distinctive clinical, epidemiological and immunological types of infection. Journal of the American Medical Association 200: 365–373, 1967

    Article  PubMed  CAS  Google Scholar 

  • Lavori P, Louis T, Bailar J, Polansky M. Designs for experiments — parallel comparisons of treatment. In Bailar & Mosteller (Eds) Medical uses of statistics, pp. 41–66, Massachusetts Medical Society, Waltham, MA, 1986

    Google Scholar 

  • Levine R. Ethics and regulation of clinical research, 2nd ed., Urban & Schwarzenberg, Baltimore-Munich, 1986

    Google Scholar 

  • Marquis D. Leaving therapy to chance. Hastings Center Report 40–47, August, 1983

  • Palca J. AIDS drug trials enter new age. Science 246: 19–21, 1989

    Article  PubMed  CAS  Google Scholar 

  • Report of the Royal College of Physicians. Research involving patients. In Williams C (Ed.) Introducing new treatments for cancer: practical, ethical, and legal problems, pp. 39–48, John Wiley & Sons, Chichester, 1992

  • Roizen R. Why I oppose drug company payment of physician/ investigators on a per patient/subject basis. IRB 10: 9–10, 1988

    Article  PubMed  Google Scholar 

  • Shimm D, Spece R. Industry reimbursement for entering patients into clinical trials: legal and ethical issues. Annals of Internal Medicine 115: 148–151, 1991a

    PubMed  CAS  Google Scholar 

  • Shimm D, Spece R. Conflict of interest and informed consent in industry sponsored clinical trials. Journal of Legal Medicine 12: 477–513, 1991b

    Article  PubMed  CAS  Google Scholar 

  • Shimm D, Spece R. Rate of refusal to participate in clinical trials. IRB 14: 7–9, 1992

    Article  PubMed  Google Scholar 

  • Spiro H. Mammon and medicine: the rewards of clinical trials. Journal of the American Medical Association 255: 1174–1175, 1986

    Article  PubMed  CAS  Google Scholar 

  • Swedberg K, Held P, Kjekshus J, Rasmussen K, Ryden R, et al. Effects of the early administration of enalapril on mortality in patients with acute myocardial infarction: results of the Cooperative New Scandinavian Enalapril Survival Study II (CONSENSUS II). New England Journal of Medicine 327: 678–684, 1992

    Article  PubMed  CAS  Google Scholar 

  • Taylor K, Margolese R, Soskolne C. Physicians’ reasons for not entering eligible patients in a randomized clinical trial for breast cancer. New England Journal of Medicine 310: 1363–1367, 1984 21 United States Code, Section 355 (i), 1972

    Article  PubMed  CAS  Google Scholar 

  • University Group Diabetes Program. A study of the effects of hypoglycemic agents on vascular complications in patients with adult onset diabetes. Diabetes 19 (Suppl. 2): pp. 747–830, 1970

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Departments of Radiation Oncology and Internal Medicine, University of Arizona College of Medicine, 1501 North Campbell Avenue, Tucson, Arizona, 85724, USA

    David S. Shimm

  2. University of Arizona College of Law, Tucson, Arizona, USA

    Roy G. Spece

Authors
  1. David S. Shimm
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Roy G. Spece
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Shimm, D.S., Spece, R.G. Ethical Issues and Clinical Trials. Drugs 46, 579–584 (1993). https://doi.org/10.2165/00003495-199346040-00001

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00003495-199346040-00001

Keywords

Search

Navigation