Sequential Design
Sequential and group sequential trial designs allow a study to be stopped early — or continued — based on interim analyses conducted as data accumulate. The core framework was formalised by O'Brien and Fleming in 1979 and extended by Lan and DeMets's alpha-spending approach, and it controls the overall Type I error rate across all planned looks by pre-specifying both efficacy and futility boundaries before enrolment begins.
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- O'Brien, P.C. & Fleming, T.R. (1979). A Multiple Testing Procedure for Clinical Trials. Biometrics, 35(3), 549–556. · DOI 10.2307/2530245
- Jennison, C. & Turnbull, B.W. (2000). Group Sequential Methods with Applications to Clinical Trials. CRC Press. · ISBN 978-0849303166
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