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Clinical Guidelines Session

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

Abstract

In introducing this session, Dr. Laurence made the following observations:
  1. 1.

    In most countries, attempts at regulation of drug registration began after the thalidomide catastrophe. In the U.K. the regulation of drug development was originally based on the assumption that regulators would be reasonable if drug companies provided good scientific studies.

     
  2. 2.

    Opinions can (and do) differ about what is “reasonable.” These differences have resulted in increased attention to the idea of guidelines in the U.K. and elsewhere. The request for guidelines in the U.K. has come mainly from the companies.

     
  3. 3.

    Although there is general agreement among members of the scientific community that guidelines should be flexible, they are in fact often interpreted quite rigidly as minimal requirements.

     

Keywords

Drug Company Multiple Criterion Antidepressant Drug Therapy Clinical Investigator CLiNICAL Requirement 
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.

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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

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