Advertisement

Clinical trials in the natural environment

  • Louis Lasagna

Abstract

In the last 40 years there has been a radical change in the ways of obtaining information about therapeutic agents that are considered valid by the scientific establishment and by national regulatory authorities. We have witnessed the ascendancy of the randomized, double-blind, controlled clinical trial (RCCT), to the point where many in positions of authority now believe that data obtained via this technique should constitute the only basis for registering a drug, or indeed for coming to any conclusions about its efficacy at any time in the drug’s career. My thesis is that this viewpoint is untenable, needlessly rigid, unrealistic, and at times unethical.

Keywords

Status Epilepticus National Regulatory Authority Folklore Medicine Unborn Fetus Cholestyramine Resin 
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.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Bailar JC III, Louis TA, Lavori PW, Polansky M (1984) Studies without internal controls. New Engl J Med 311: 156–162PubMedCrossRefGoogle Scholar
  2. 2.
    Moses LE (1984) The series of consecutive cases as a device for assessing outcomes of intervention. New Engl J Med 311: 705–710PubMedCrossRefGoogle Scholar
  3. 3.
    Archer JD (1984) The FDA does not approve uses of drugs. JAMA 252: 1054–1055PubMedCrossRefGoogle Scholar
  4. 4.
    Lasagna L (1982) Historical controls — the practitioner’s clinical trials. New Engl J Med 307: 1339–1340PubMedCrossRefGoogle Scholar
  5. 5.
    Hill AB (1966) Heberden Oration, 1965. Reflections on the controlled trial. Am Rheum Dis 25: 107–113Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 1985

Authors and Affiliations

  • Louis Lasagna
    • 1
  1. 1.Tufts UniversityBostonUSA

Personalised recommendations