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READING AND ASSESSING REPORTS OF TREATMENT STUDIES IN ONCOLOGY - 06/09/11

Doi : 10.1016/S0039-6109(05)70197-3 
Richard Simon, DSc *

Resumen

The year 1998 marked the 50th anniversary of the introduction of the modern clinical trial to medicine. The trial was designed by Austin Bradford Hill for the evaluation of streptomycin for treatment of pulmonary tuberculosis. After centuries of enduring various erroneous methods resulting in persistence of ineffective and morbid treatments, a methodology was developed that produced consistently reliable answers and that largely avoided the biases of medical authorities. The introduction of the randomized, clinical trial transformed medicine into an experimental science. The essence of the clinical trial is to ask an important well-defined question and to get a reliable answer.9 The important question is usually whether administration of a well-defined treatment to a well-defined population of patients produces a better distribution of a medically important outcome than a placebo or control treatment or no treatment. Surgeons and oncologists today are presented with many claims of treatment efficacy that they must assess. In many cases, the evidence supporting the claims is weak, although the weakness may be masked by high-tech luster and authoritative pronouncements. This article reviews the principles of the modern clinical trial to provide guidance for reading the medical literature and assessing claims of therapeutic efficacy.

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 Address reprint requests to Richard Simon, DSc, Biometric Research Branch, National Cancer Institute, National Institutes of Health, 9000 Rockville Pike, Building EPN, Room 739, Bethesda, MD 20892


© 2000  W. B. Saunders Company. Publicado por Elsevier Masson SAS. Todos los derechos reservados.
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Vol 80 - N° 2

P. 487-494 - avril 2000 Regresar al número
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