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Sample Size Reassessment in Adaptive Clinical Trials Using a Bias Corrected Estimate
Author(s) -
Coburger Silke,
Wassmer Gernot
Publication year - 2003
Publication title -
biometrical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.108
H-Index - 63
eISSN - 1521-4036
pISSN - 0323-3847
DOI - 10.1002/bimj.200390051
Subject(s) - sample size determination , estimator , statistics , estimation , point estimation , clinical trial , mathematics , adaptive design , econometrics , sample (material) , medicine , chemistry , management , pathology , chromatography , economics
Point estimation in group sequential and adaptive trials is an important issue in analysing a clinical trial. Most literature in this area is only concerned with estimation after completion of a trial. Since adaptive designs allow reassessment of sample size during the trial, reliable point estimation of the true effect when continuing the trial is additionally needed. We present a bias adjusted estimator which allows a more exact sample size determination based on the conditional power principle than the naive sample mean does.