p-value and power computations in multiple look trials

This paper presents at an instructive level detailed design, decision and computational aspects of p-values and power for clinical trials in which interim looks at accumulating data are planned. Background theory and an application are presented. In addition, a definition of the term p-value, approp...

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Bibliographic Details
Published in:Journal of chronic diseases Vol. 40; no. 1; p. 23
Main Authors: Peace, K E, Schriver, R C
Format: Journal Article
Language:English
Published: England 1987
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Summary:This paper presents at an instructive level detailed design, decision and computational aspects of p-values and power for clinical trials in which interim looks at accumulating data are planned. Background theory and an application are presented. In addition, a definition of the term p-value, appropriate for a trial in which interim looks are planned is proposed. The definition is intuitively consistent with that for a fixed sample size trial. That is, the p-value reflects the strength of the data against the null hypothesis. For trials incorporating group sequential methods, the p-value at a particular look reflects the conditional nature of the data collected through that look on the data collected through earlier looks.
ISSN:0021-9681
DOI:10.1016/0021-9681(87)90093-2