Clinical trials in the natural environment
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.
KeywordsStatus Epilepticus National Regulatory Authority Folklore Medicine Unborn Fetus Cholestyramine Resin
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- 5.Hill AB (1966) Heberden Oration, 1965. Reflections on the controlled trial. Am Rheum Dis 25: 107–113Google Scholar