The double blind, placebo controlled clinical trial (PCT) has been for many years the most rigorous and compelling method for demonstrating the efficacy of new therapeutic agents. Despite this, concerns have been expressed in the medical literature that there is misuse of the PCT and that such misuse is being driven by the requirements of the pharmaceutical industry and pharmaceutical regulatory authorities. In this paper a brief general overview of the advantages and disadvantages of the PCT is provided and comments are made on its use for pharmaceutical registration and regulatory purposes.
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