Group sequential designs for phase II trials with historical controls.
Two-step tests based on historical control data are proposed for detecting different means when experimental and control populations are normally distributed with possibly different known variances. The results readily extend to the case where the control and experimental data are dichotomous. Provisions for early acceptance and early rejection are included.
Chang
M N
MN
Department of Statistics, University of Florida, Gainesville 32601-3330, USA.
Shuster
J J
JJ
Kepner
J L
JL
D000704:Analysis of Variance; D017322:Clinical Trials, Phase II as Topic / Q000706:statistics & numerical data*; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D006801:Humans; D016011:Normal Distribution; D015203:Reproducibility of Results; D012189:Retrospective Studies