Clinical trials in the natural environment

  • Louis Lasagna


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.


Status Epilepticus National Regulatory Authority Folklore Medicine Unborn Fetus Cholestyramine Resin 
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Copyright information

© Springer-Verlag Berlin Heidelberg 1985

Authors and Affiliations

  • Louis Lasagna
    • 1
  1. 1.Tufts UniversityBostonUSA

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