Group sequential designs for Phase II trials with historical controls

Authors
Chang, MN Shuster, JJ Kepner, JL
Citation
Mn. Chang et al., Group sequential designs for Phase II trials with historical controls, CONTR CL TR, 20(4), 1999, pp. 353-364
Citations number
7
Categorie Soggetti
Pharmacology,"Medical Research General Topics
Journal title
CONTROLLED CLINICAL TRIALS
ISSN journal
01972456 → ACNP
Volume
20
Issue
4
Year of publication
1999
Pages
353 - 364
Database
ISI
SICI code
0197-2456(199908)20:4<353:GSDFPI>2.0.ZU;2-F
Abstract
Two-step tests based on historical control data are proposed for detecting different means when experimental and control populations are normally dist ributed with possibly different known variances. The results readily extend to the case where the control and experimental data are dichotomous. Provi sions for early acceptance and early rejection are included. Control Clin T rials 1999;20:353-364 (C) Elsevier Science Inc. 1999.