Report: The Scientific and Ethical Basis of the Clinical Evaluation of Medicines

  • William M. Wardell
  • Giampaolo Velo
Part of the NATO Advanced Study Institutes Series book series (NSSA, volume 39)


The scientific basis of the clinical evaluation of medicines is well established, and clinical investigators have also given considerable attention to the ethical problems. But of recent years there has been increasing concern with and critcism of the ethics of these procedures. Lawyers, medical doctors and others have expressed the opinion that the randomised controlled therapeutic trial subordinates the rights of the individual to the advantages of society to a degree that can even be “criminal.” Clinical investigators must respond to such criticism, even if it stems only from a few individuals. Therefore, a conference was convened on this topic. The scientific basis of evaluation of medicines in man was reviewed and found to be in accord with the best ethical standards. The objections that have been advanced were considered and were found to be both misconceived and liable to lead to the proliferation of medicines inadequately evaluated for efficacy and safety, to the disadvantage of society.


Therapeutic Trial Ethical Problem Clinical Investigator Ethical Basis Individual Ethic 
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.
    R. Burkhardt and G. Kienle, Controlled clinical trials and medical ethics, Lancet 2: 1356 (1978).CrossRefGoogle Scholar
  2. 2.
    Editorial, Controlled trials: Planned deception?, Lancet 1: 534 (1979).Google Scholar
  3. 3.
    P. Armitage, “Sequential Medical Trials,” Oxford (1975).Google Scholar

Copyright information

© Springer Science+Business Media New York 1981

Authors and Affiliations

  • William M. Wardell
    • 1
  • Giampaolo Velo
    • 2
  1. 1.The University of Rochester School of Medicine and DentistryRochesterUSA
  2. 2.University of PaduaVeronaItaly

Personalised recommendations