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July 2021

THE CLINICAL TRIAL-SOME DIFFICULTIES AND SUGGESTIONS

Journal/Book: JOURNAL OF CHRONIC DISEASES St. Louis Vol. 11 No. 5 Pages 484-496 May 1960. 1960;

Abstract: DONALD MAINLAND M.B. Ch.B. D.Sc. New York N . Y. From the Department of Medical Statistics New York University College of Medicine*Received for publication July 20 1959 This paper was written under a project entitled "Promotion of Biometrical Methods in Medical Research supported by a gram (RG-6100) from the U. S. Public Health Service. *550 First Ave., New York 16, N. Y. IN 1949, at the New York Academy of Sciences, there was held a conference an The Place of Statistical Methods in Biological and Chemical Experimentation."1 Those who presented papers included workers in the pharmaceutic industry chemistry and the Food and Drug Administration and two medical investigators who spoke about controlled clinical trials. Audience discussion showed familiarity with modern ideas of design and analysis except for the questions asked by a doctor who revealed the lack of understanding and consequent suspicion of controlled trials which at that time prevailed in medicine. In 1958 at a meeting of the Endocrine Society in San Francisco a panel of six cancer specialists was presented with case histories of patients who had mammary or prostatic cancer and on each case the panel was asked to express opinions regarding appropriate therapies. Differences of opinion were of course considerable and panel members voiced their belief that the only sound basis for opinion was a controlled trial double blind if possible with appropriate stratification randomization of patients to the therapies under test and proper analysis of the results. A STATISTICAL ATTITUDE The contrast between the 1949 conference and the 1958 panel-meeting illustrates a change that has become widespread in clinical medicine during the intervening years. The 1958 attitude is a "statistical" attitude whether we think of statistics as the principles that experimenters have used for centuries to obtain valid results in the face of omnipresent variation in the material studied in methods of measurement and in observers or whether we restrict the term artificially to some methods such as randomization which workers who bear the label "statistician" have recently introduced into experimentation. Whatever we may call the concepts and methods the striking feature is that now they are preached and practiced by an increasing number of clinical investigators whereas a decade ago anyone who advocated them was commonly regarded as an aberrant specimen. ... ___MH


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