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Estimation of a Parameter and Its Exact Confidence Interval Following Sequential Sample Size Reestimation Trials
Author(s) -
Cheng Yi,
Shen Yu
Publication year - 2004
Publication title -
biometrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.298
H-Index - 130
eISSN - 1541-0420
pISSN - 0006-341X
DOI - 10.1111/j.0006-341x.2004.00246.x
Subject(s) - coverage probability , sample size determination , confidence interval , point estimation , statistics , nominal level , mathematics , inference , interval estimation , tolerance interval , computer science , artificial intelligence
Summary For confirmatory trials of regulatory decision making, it is important that adaptive designs under consideration provide inference with the correct nominal level, as well as unbiased estimates, and confidence intervals for the treatment comparisons in the actual trials. However, naive point estimate and its confidence interval are often biased in adaptive sequential designs. We develop a new procedure for estimation following a test from a sample size reestimation design. The method for obtaining an exact confidence interval and point estimate is based on a general distribution property of a pivot function of the Self‐designing group sequential clinical trial by Shen and Fisher (1999, Biometrics 55, 190–197). A modified estimate is proposed to explicitly account for futility stopping boundary with reduced bias when block sizes are small. The proposed estimates are shown to be consistent. The computation of the estimates is straightforward. We also provide a modified weight function to improve the power of the test. Extensive simulation studies show that the exact confidence intervals have accurate nominal probability of coverage, and the proposed point estimates are nearly unbiased with practical sample sizes.