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Ethics of Drug Research and Drug Development

  • Conference paper
Drug Research and Drug Development in the 21st Century

Part of the book series: Bayer AG Centenary Symposium ((BAYER))

Abstract

Medical benefits of clinical research during the past hundred years include effective vaccines and drugs for fighting most infections, the virtual eradication of epidemic diseases such as smallpox and cholera, an impressive reduction in infant mortality and the prevention of diseases such as polio and pertussis, transplantation of vital organs such as heart, kidneys, and liver, and impressively improved life-expectancy rates for patients suffering stroke, heart disease, or cancer. Life expectance overall has increased impressively and medical benefits can easily be translated into social, economic, cultural, and moral benefits. Quantitative and qualitative evidence regarding the impact of the result of clinical investigations in everyday life suggests that clinical research is not only morally acceptable, but morally mandated [1, 23, 25].

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References

  1. Beecher HK (1966) Ethics and clinical research. N Engl J Med 274: 1354–1360

    Article  PubMed  CAS  Google Scholar 

  2. Brewin TB (1982) Consent to randomized treatment. Lancet II: 919–921

    Article  Google Scholar 

  3. Engelhardt HT (1988) Diagnosing well and treating prudently. In: Spicker SF, et al. (eds) The use of human beings in research. Kluwer, Dordrecht, pp 123–141

    Chapter  Google Scholar 

  4. Fagot-Largeault AM (1988) Epitemological presuppositions involved in the programs of human research. In: Spicker SF, et al. (ed) The use of human beings in research. Kluwer, Dordrecht, pp 161–187

    Chapter  Google Scholar 

  5. Feinstein AR (1967) Clinical judgement. Krieger, Huntington

    Google Scholar 

  6. Feinstein AR (1977) Clinical biostatistics. Mosby, St. Louis

    Google Scholar 

  7. Freedman B (1987) Equipoise and the ethics of clinical research. N Engl J Med 317 (3): 141–145

    Article  PubMed  CAS  Google Scholar 

  8. Freireich EJ (1988) Ethical issues in clinical trials. Biomed Pharmacother 42: 157–158

    PubMed  CAS  Google Scholar 

  9. Gehan EA (1988) Methodological issues in cancer clinical trials: the comparison of therapies. Biomed Pharmacother 42: 161–165

    PubMed  CAS  Google Scholar 

  10. Gifford F (1986) The conflict between randomized clinical trials and the therapeutic obligation. J Med Philos 11: 347–366

    PubMed  CAS  Google Scholar 

  11. Gray BH (1975) Human subjects in medical experimentation. Wiley, New York

    Google Scholar 

  12. Guyatt G, Sackett D, et al. (1986) Determining optimal therapy–randomized trials in individual patients. N Engl J Med 314 (14): 889–892

    Article  PubMed  CAS  Google Scholar 

  13. Helsinki/Tokyo Declaration on Biomedical Research 1975 (1978) In: Reich WT (ed) Encyclopedia of bioethics, vol 4. Macmillan, London, pp 1771–1773

    Google Scholar 

  14. Hurst J (1987) New attitudes in assessing benefits. In: Smith GT (ed) Costs and benefits of pharmaceutical research. Office of Health Economics, London, pp 18–24

    Google Scholar 

  15. Kadane JB (1986) Progress toward a more ethical method for clinical trials. J Med Philos 11: 385–404

    PubMed  CAS  Google Scholar 

  16. Koppelman L (1986) Consent or randomized clinical trials: are there moral or design problems? J Med Philos 11: 317–345

    Google Scholar 

  17. Kos Statement on Randomization 1986/1987 (1988) Biomed Pharmacother 42: 167

    Google Scholar 

  18. Marquis D (1986) An argument that all prerandomized clinical trials are unethical. J Med Philos 11: 367–383

    PubMed  CAS  Google Scholar 

  19. Mathe G, Brienza S (1988) From methodology to ethics and from ethics to methodology. Biomed Pharmacother 42: 143–153

    PubMed  CAS  Google Scholar 

  20. Moroff SV (1986) Qualitative and ethical issues in quantitative clinical decision-making. NY State J Med 86: 250–253

    CAS  Google Scholar 

  21. Moser M (1986) Randomized clinical trials: problems and values. Am J Emerg Med 4 (2): 173–178

    Article  PubMed  CAS  Google Scholar 

  22. Sass HM (1983) Reichsrundschreiben 1931, Pre-Nuremberg regulations concerning new therapy and human experimentation. J Med Philos 8: 101–113

    Google Scholar 

  23. Sass HM (1987) Philosophical and moral aspects of manipulation and risk. Swiss Biotech 5 (2a): 50–56

    PubMed  Google Scholar 

  24. Sass HM (1988) Comparative models and goals for the regulation of human research. In: Spicker SF, et al. (ed) The use of human beings in research. Kluver, Dordrecht, pp 47–89

    Chapter  Google Scholar 

  25. Sass HM (1989) Ethische Kosten-Nutzen Analyse. Zentrum für Medizinische Ethik Bochum, Medizinethische Materialien No. 22

    Google Scholar 

  26. Sass HM (1989a) Brainlife and braindeath. J Med Philos 14: 45–59

    PubMed  CAS  Google Scholar 

  27. Sass HM (1989b) Blue-ribbon commissions and political ethics in the Federal Republic of Germany. J Med Philos 14 (4) (in print)

    Google Scholar 

  28. Sassower R, Grodin MA (1987) Scientific uncertainty and medical responsibility. Theor Med 8: 221–234

    Article  PubMed  CAS  Google Scholar 

  29. Schaffner KF (1986) Ethical problems in clinical trials. J Med Philos 11: 297–315

    PubMed  CAS  Google Scholar 

  30. Spicker SF (1988) Research risks, randomization, and risk to research. In: Spicker SF, et al. (ed) The use of human beings in research. Kluwer, Dordrecht, pp 143–160

    Chapter  Google Scholar 

  31. US Department of Health and Human Services (1987) Investigational new drug, antibiotic, and biological drug product regulations (21 CFR part 312). Federal Register 52 (no 99), pp 19466–77

    Google Scholar 

  32. US President’s Commission (1983) Implementing human research regulations ( 83600504 ). Government Printing Office, Washington DC

    Google Scholar 

  33. von Eickstedt KW (1983) The ethical position of the attending physician in phase III of clinical investigations. Int J Clin Pharm Ther Toxicol 21 (10): 529–534

    Google Scholar 

  34. Zelen M (1979) A new design for randomized clinical trials. New Engl J Med 300: 1242–1245

    Article  PubMed  CAS  Google Scholar 

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© 1989 Springer-Verlag Berlin Heidelberg

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Sass, HM. (1989). Ethics of Drug Research and Drug Development. In: Wolff, HP., Fleckenstein, A., Philipp, E.O. (eds) Drug Research and Drug Development in the 21st Century. Bayer AG Centenary Symposium. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-74615-4_23

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  • DOI: https://doi.org/10.1007/978-3-642-74615-4_23

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-540-50961-5

  • Online ISBN: 978-3-642-74615-4

  • eBook Packages: Springer Book Archive

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