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Clinical Trials

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Book cover Surgical Research

Abstract

Surgery is constantly changing, and some of the changes are dramatic advances instantly recognizable for their benefit to patients. William T.G.Morton’s administration of ether anesthesia to John Collins Warren’s patient on October 14,1846, required no confirmation. Warren’s immediate and definitive conclusion—“Gentlemen,this is no humbug!”—was soon accepted throughout the world. A similar example is the introduction of antibiotics into clinical practice in the 1940s.

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References

  1. Bearman JE, Loewenson RB, Gullen WH. Muench’s Postulates, Laws, and Corollaries, or Biometricians’ Views on Clinical Studies. (Biometrics Note 4)Bethesda, MD: Office of Biometry and Epidemiology, National Eye Institute, National Institutes of Health, 1974

    Google Scholar 

  2. Goligher JC, Pulvertaft CN, Watkinson G. Controlled Trial of Vagotomy and Gastro-Enterostomy, Vagotomy, and Antrectomy, and Subtotal Gastrectomy in Elective Treatment of Duodenal Ulcer: Interim Report. Br Med J 1964;1:455–460

    Article  PubMed  CAS  Google Scholar 

  3. Freedman B. Equipoise and the Ethics of Clinical Research. New Engl J Med 1987;317:141–145

    Article  PubMed  CAS  Google Scholar 

  4. Baillar JC III. Introduction. In: Shapiro SH, Lewis TA, eds. Clinical Trials, Issues, and Approaches. New York: Marcel Dekker, 1983, p. 1

    Google Scholar 

  5. Herman J. The Emise of the Randomized Cntrolled Trial. J Clin Epidemiol 1995;48:985–988

    Article  PubMed  CAS  Google Scholar 

  6. Sacket DL. On Some Prerequisites for a Successful Clinical Ctrial. In: Shapiro SH, Louis TA, eds. Clinical Trials. New York: Marcel Dekker, 1983, p 65

    Google Scholar 

  7. Gilbert JP, McPeek B, Mosteller F. Statistics and Ethics in Surgery and Anesthesia. Science 1977; 198:684–689

    Article  PubMed  CAS  Google Scholar 

  8. Moses LE, Louis TA. Statistical Consultation in Clinical Research: A Two-Way Street. In: Baillar JC, Mosteller F, eds. Medical Uses of Statistics, 2nd edn. Boston: NEJM Books, 1992, pp. 349–356

    Google Scholar 

  9. Pocock S. Clinical Trials—A Practical Approach. New York: Wiley, 1983

    Google Scholar 

  10. Friedman LM, Furberg CD, DeMetz DL. Fundamentals of Clinical Trials, 2nd edn. Littleton, MA: Littleton Publishing Co, 1985:1–307

    Google Scholar 

  11. Schwartz D, Lellouch J. Explanatory and Pragmatic Attitudes in Clinical Trials. J Chronic Dis 1967;20:637–648

    Article  PubMed  CAS  Google Scholar 

  12. MacRae KD. Pragmatic Versus Explanatory Trials. Int J Technol Assess Health Care 1989;5:333–339

    Article  CAS  Google Scholar 

  13. Meinert CL. Clinical Trials—Design, Conduct, and Analysis. New York: Oxford University 1986

    Google Scholar 

  14. Zelen M, Gehan E, Glibwell O. Biostatistics in Cancer Research. In: Hoogstralen B, ed. Importance of Cooperative Groups. New York: Mason, 1980, pp. 291–312

    Google Scholar 

  15. Mosteller F, Gilbert JP, McPeek B. Reporting Standards and Research Strategies for Controlled Trials. Controlled Clin Trials 1980;1:37–58

    Article  Google Scholar 

  16. Freiman JA, Chalmers TC, Smith H. The Importance of Beta, the Type II Error, and Sample Size in the Design and Interpretation of the Randomized Controlled Trial. New Engl J Med 1978;290:690–694

    Article  Google Scholar 

  17. Emerson JD, McPeek B, Mosteller F. Reporting Clinical Trials in General Surgical Journals. Surgery 1984;85:572–579

    Google Scholar 

  18. Shapiro S, Louis A, eds. Clinical Trials: Issues and Approaches. New York: Dekker, 1982

    Google Scholar 

  19. Lebacqz K. Ethical Aspects of Clinical Trials. In: Shapiro SH, Lewis TA, eds. Clinical Trials, Issues, and Approaches. New York: Marcel Dekker, 1983, pp. 81–98

    Google Scholar 

  20. Moss AJ, Hall WJ, Cannom DS, Daubert JP, Hig-gins SL, Klein H, Levine JH, Saksena S, Waldo AL, Wilber D, Brown MW, Heo M. Improved Survival With an Implanted Defibrillator in Patients With Coronary Disease at High Risk for Ventricular Arrhythmia. New Engl J Med 1996;335:1933–1940

    Article  PubMed  CAS  Google Scholar 

  21. Schwartz D, Flamant R, Lellouch J. Clinical Trials. New York: Academic, 1980

    Google Scholar 

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Authors
  1. M. F. McKneally
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  2. B. McPeek
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  3. F. Mosteller
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  4. E. A. M. Neugebauer
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Editor information

Editors and Affiliations

  1. Department of Surgery, University of Cologne, Ostmerheimer Strasse 200, D-51109, Cologne, Germany

    H. Troidl

  2. Joint Centre for Bioethics, and The Toronto Hospital, University of Toronto, 200 Elizabeth Street EN 10-230, Toronto, Ontario, M5G 2C4, Canada

    M. F. McKneally

  3. Department of Surgery, McGill University, Montreal General Hospital, Montreal, Quebec, Canada, H3G 1A4

    D. S. Mulder

  4. Department of Surgery, Medical College of Virginia, Virginia Commonwealth University, Richmond, VA, 23298-0645, USA

    A. S. Wechsler

  5. Department of Anaesthesia, Harvard University, Massachusetts General Hospital, Boston, MA, 02114-2696, USA

    B. McPeek

  6. Genentech, Inc., 460 Point San Bruno Boulevard, South San Francisco, California, 94080-4990, USA

    W. O. Spitzer

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© 1998 Springer Science+Business Media New York

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McKneally, M.F., McPeek, B., Mosteller, F., Neugebauer, E.A.M. (1998). Clinical Trials. In: Troidl, H., McKneally, M.F., Mulder, D.S., Wechsler, A.S., McPeek, B., Spitzer, W.O. (eds) Surgical Research. Springer, New York, NY. https://doi.org/10.1007/978-1-4612-1888-3_26

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  • DOI: https://doi.org/10.1007/978-1-4612-1888-3_26

  • Publisher Name: Springer, New York, NY

  • Print ISBN: 978-1-4612-7325-7

  • Online ISBN: 978-1-4612-1888-3

  • eBook Packages: Springer Book Archive

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