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Controlling Alpha in a Clinical Trial: the Case for Secondary Endpoints by Ralph B. D'Agostino Sr is a Mathematics article available to read on EtoBox.

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We have become masters of clinical trials. We design them beautifully, our protocols delineate objectives and categorize sharply e$cacy variables as primary or secondary, teams of investigators execute them e$ciently and then we analyse with the latest and most sophisticated statistical methods. Yet, all too often, they fail, being negative on the primary e$cacy variable and positive on a secondary endpoint. Positive and negative refer solely to attaining or not attaining statistical signi"cance. Statisticians try to interpret these trials. Some hold the position that the entire study is negative because the primary e$cacy variable does not achieve statistical signi"cance. For them, analyses of secondary variables are, at best, exploratory and no con"rmatory conclusions can be made. This position has the logic of adhering to a strict code of alpha spending. If the primary e$cacy variable is not signi"cant, then all the alpha has been spent and no further con"rmatory looks of the data are possible. Other statisticians oppose this stance as too rigid and argue to continue the analyses, and then judge the study as positive or negative depending on the importance of the signi"cant seco

Who reads Controlling Alpha in a Clinical Trial: the Case for Secondary Endpoints?

Author

Ralph B. D'Agostino Sr

Publisher

John Wiley and Sons; Wiley (John Wiley & Sons); John Wiley & Sons Inc.; Wiley (ISSN 0277-6715)

Published

2000

Language

EN

Field

Mathematics (Physical Sciences)