The origins of modern clinical research.
The single-blind or double-blind, placebo-controlled randomized clinical trial is considered the gold standard for evaluating the potential efficacy of pharmaceuticals, medical devices, and treatment protocols. The characteristic features of placebo-controlled clinical evaluations include two essential elements: a sham intervention and subject ignorance about the bogus nature of that intervention. Although it commonly is assumed that such clinical trials were developed in the 1930s, the first published report that used intentional subject ignorance and sham intervention was the result of a 1784 French royal commission investigation into mesmerism, headed by Benjamin Franklin. The strategy the Franklin commission used to debunk Franz Mesmer's assertions about health and illness served as a model for subsequent inquiries that use placebo controls and blinded assessment to arrive at their conclusions.
Green
Stuart A
SA
Department of Orthopaedic Surgery, University of California, Irvine, Irvine, CA 92868, USA. sgreen@uci.edu
D035843:Biomedical Research / Q000266:history*; D002986:Clinical Trials as Topic / Q000266:history*; D005602:France; D049671:History, 18th Century; D006990:Hypnosis / Q000266:history; D008280:Magnetics / Q000266:history