The use of statistical methods in the analysis of clinical studies.
It is "standard" to analyze data from a clinical trial using a narrowly defined probabilistic mathematical model. This paper examines the ways in which mathematical models, in general, can be used in clinical research, the meaning of probability in the examination of clinical trials, and the philosophical flaws in the current "standard" method. An alternative formulation is proposed which is more flexible and which comes closer to meeting the needs of medical science. In this alternative formulation, significance tests are applied to the data from a study only as a first step to determine whether the data are worth further examination. After that, clinically relevant questions are answered with 50 and 95% confidence bounds. The initial significance test is tailored to be directed at a narrow class of hypotheses that, in turn, are dictated by clinical expectations.
Salsburg
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Central Research Division, Pfizer Inc., Groton, CT 06340.
D002986:Clinical Trials as Topic; D003627:Data Interpretation, Statistical; D006801:Humans; D015233:Models, Statistical; D011336:Probability