Some extensions to a new approach for interim analysis in clinical trials.
There already exists many methods for group sequential analysis of clinical trials. A new approach suggests to preserve the overall type I error alpha by requiring that a succession of interim analyses be significant at the alpha level. In this paper, this procedure is extended. A rule for early acceptance of H0 is presented, with an extension for flexible number and times of analyses. A real example is given.
Falissard
B
B
INSERM U 169, Villejuif, France.
Lellouch
J
J
D002986:Clinical Trials as Topic / Q000379:methods*; D003627:Data Interpretation, Statistical; D008432:Mathematical Computing; D011336:Probability; D012107:Research Design