Principles of Clinical Drug Trials

  • G. K. Krieglstein
Conference paper


The introduction of a new drug often raises the justified question about the procedure to which a chemically defined active compound is submitted before it is available as a commercial product to the medical profession. In view of the updated rules governing the safety of drugs this is indeed a costly procedure and so it is not surprising that only one out of about 6,000 to 10,000 synthetisised substances is approved as a drug for clinical use. In many cases the complete development period may take up to ten years and the costs may be in the range of 80 million DM.


Control Clinical Trial Costly Procedure Placebo Therapy Clinical Drug Trial Short Period Treatment 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Ballintine, E. J.: Objective measurements and the doublemasked procedure. Amer. J. Ophthalmol. 79, 763–767 (1975).Google Scholar
  2. 2.
    Bearman, J. E.: Writing the protocol for a clinical trial. Amer. J. Ophthalmol. 79, 775–778 (1975).Google Scholar
  3. 3.
    Chalmers, T. C.: Ethical aspects of clinical trials. Amer. J. Ophthalmol. 79, 753–758 (1975).Google Scholar
  4. 4.
    Davis, M. D.: Application of the princicples of clinical trials. Amer. J. Ophthalmol. 79, 779–785 (1975).Google Scholar
  5. 5.
    Domschke, S., Domschke, W.: Arzneimittelprüfung heute. Fortschr. Med. 99, 814–818 (1981).PubMedGoogle Scholar
  6. 6.
    Ederer, F.: Why do we need controls? Why do we need to randomize? Amer. J. Ophthalmol. 79, 758–762 (1975).Google Scholar
  7. 7.
    Fink, H.: Grundsätze des kontrollierten Versuchs. Arzneim.-Forsch./ Drug Res. 28, 2017–2019 (1978).Google Scholar
  8. 8.
    Gross, R.: Notwendigkeit und Zulässigkeit der kontrollierten klinischen Prüfung. DA 16, 1091–1100 (1979).Google Scholar
  9. 9.
    Hartmann, E.: Nicht-randomisierte Therapiestudien. Arzneim.-Forsch./ Drug Res. 28, 2027–2032 (1978).Google Scholar
  10. 10.
    Herman, Z. S.: The principles of controlled clinical trials of drugs. Int. J. clin. Pharmacol. 16, 361–364 (1978).Google Scholar
  11. 11.
    Kahn, A. H., Leibowitz, H., Ganley, J. P., Kini, M., Colton, T., Nickerson, R., Dawber, R.: Standardizing diagnostic procedures. Amer. J. Ophthalmol. 79, 768–775 (1975).Google Scholar
  12. 12.
    Kohlhaas, M.: Rechtliche Probleme der klinischen Pharmakologie und Therapie. In: Klinische Pharmakologie und Pharmakotherapie (Kuemmerle, H. P., Garrett, E. R., Spitzy, K. H., eds.), 3rd ed. MünchenBerlin—Wien: Urban & Schwarzenberg. 1976.Google Scholar
  13. 13.
    Kupfer, C.: The role of clinical drug trial methodology with respect to studies of new drugs. Clinical trials of timolol. Surv. Ophthalmol. 23, 399–401 (1979).PubMedCrossRefGoogle Scholar
  14. 14.
    McMahon, G. F.: The effects of new federal regulation on clinical investigation. Clin. Pharmacol. Ther. 23, 495–496 (1978).PubMedGoogle Scholar
  15. 15.
    Probst, M., Fabian, W.: Zur Durchführung von prospektiven kontrollierten randomisierten Studien in der Klinik. Fortschr. Med. 98, 1–14 (1980).PubMedGoogle Scholar
  16. 16.
    Remington, R. C.: Problems of university-based scientists associated with clinical trials. Clin. Pharmacol. Ther. 25, 662–665 (1979).PubMedGoogle Scholar
  17. 17.
    Sommer, A.: Epidemiology and statistics for the ophthalmologist, pp. 1–86. New York: Oxford University Press. 1980.Google Scholar
  18. 18.
    Wolf, G. K.: Probleme in der Anwendung statistischer Methoden bei Therapiestudien. Fortschr. Med. 99, 803–823 (1981).PubMedGoogle Scholar

Copyright information

© Springer-Verlag Wien 1984

Authors and Affiliations

  • G. K. Krieglstein
    • 1
    • 2
  1. 1.University Eye ClinicWürzburgFederal Republic of Germany
  2. 2.Universitäts-AugenklinikWürzburgFederal Republic of Germany

Personalised recommendations