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- W2078602948 abstract "IN RECENT years the large-scale field trial designed to test the efficacy of prophylactic treatments has become a major tool in coronary heart disease research. The basic design of such a trial for coronary heart disease or, similarly, chronic degenerative diseases generally, consists of two groups of subjects, designated a control group and an experimental or treatment group. The goal of the trial is to detect a difference in disease incidence (if any) between the two groups. Of central importance in the design of any such trial is the minimum sample size required to show the hypothesized effect. Closely related to this minimum sample size is the selection of criteria to determine the admissibility of subjects to the study. In designing this type of study, investigators tend to favor admission only of high risk subjects to the study. One of the arguments advanced for this policy is that if high risk subjects are entered in the study there will be more opportunity for detection of treatment effects and the number of subjects required for study will be smaller. This paper discusses the relationship between subject selection criteria, sample size and the cost of a field trial and shows that, for the coronary heart disease examples below, the use of higher risk subjects in clinical trials is not generally effective in increasing statistical power or decreasing costs and in certain circumstances can actually decrease the power of the trial. To reach these conclusions we have extended the general methodology in Halperin et al. [l] to include subjects with varying degrees of risk and risk reduction potential. Thus, we consider those situations in which the a priori subject risk is not uniform over all subjects. In such trials higher risk subjects may be preferred for various reasons. Clearly, if the objective is to evaluate some treatment for primary disease, one would choose subjects with the disease-for example, in reno-vascular hypertension, surgery would be performed only on patients with high blood pressure. Sometimes ethics dictates that the subjects be patients in advanced stages of the disease, such as in many phase-I and phase-II studies in the treatment of cancer. In secondary treatment studies, moreover, the subjects are high risk patients by definition-for example, patients who have just recovered from a heart attack." @default.
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- W2078602948 date "1974-07-01" @default.
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- W2078602948 title "High risk subjects and the cost of large field trials" @default.
- W2078602948 cites W1982400467 @default.
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- W2078602948 doi "https://doi.org/10.1016/0021-9681(74)90044-7" @default.
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