1999
DOI: 10.1002/(sici)1097-0258(19990915/30)18:17/18<2271::aid-sim254>3.0.co;2-z
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A unified theory for sequential clinical trials

Abstract: The theory underlying sequential clinical trials is now well developed, and the methodology is increasingly being implemented in practice, both by the pharmaceutical industry and in the public sector. The consequences of conducting interim analyses for frequentist interpretations of data are now well understood. A large number of approaches are available for the calculation of stopping boundaries and for the eventual terminal analysis. In this paper, the principles of the design and analysis of sequential clin… Show more

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Cited by 57 publications
(31 citation statements)
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“…This is true for point estimation 5-8 as well as estimation of precision 121820 . Much of the relatively early work has been summarized by Whitehead and colleagues 21 . 20 point out that although maximum likelihood estimators are not affected by stopping rules, their sampling distribution is.…”
Section: Sampling With a Deterministic Or Probabilistic Stopping Rulementioning
confidence: 99%
“…This is true for point estimation 5-8 as well as estimation of precision 121820 . Much of the relatively early work has been summarized by Whitehead and colleagues 21 . 20 point out that although maximum likelihood estimators are not affected by stopping rules, their sampling distribution is.…”
Section: Sampling With a Deterministic Or Probabilistic Stopping Rulementioning
confidence: 99%
“…It is planned as a one‐sided (two‐sided) test of the null hypothesis H 0 : π 1 = π 0 against the one‐sided (two‐sided) alternative H 1 : π 1 > π 0 (H 1 : π 1 ≠ π 0 ). For the STT and DTT, the measure of treatment difference θ is taken to be the log odds‐ratio and the reference improvement, called θ R , is equal to: where the logarithm is to base e [3,4].…”
Section: Methodsmentioning
confidence: 99%
“…Several recent papers (van der Tweel & Bollen, ; Higgins et al . ) used group sequential procedures by Whitehead () and his package PEST in application to random effects CMA. These procedures are designed to satisfy a pre‐specified power requirement.…”
Section: Sequential Meta‐analysismentioning
confidence: 99%