title: Testing secondary hypotheses following sequential clinical trials.
abstract: Sequential monitoring in a clinical trial poses difficulty in hypotheses testing on secondary endpoints after the trial is terminated. The conventional likelihood-based testing procedure that ignores the sequential monitoring inflates Type I error and undermines power. In this article, we show that the power of the conventional testing procedure can be substantially improved while the Type I error is controlled. The method is illustrated with a real clinical trial.
authors.affiliation: Biostatistics Unit, Lombardi Cancer Center, Georgetown University Medical Center, Washington, DC 20007, USA. Liua1@gunet.georgetown.edu
authors.forename: A
authors.initials: A
authors.lastname: Liu
authors.forename: M
authors.initials: M
authors.lastname: Tan
authors.forename: J M
authors.initials: JM
authors.lastname: Boyett
authors.forename: X
authors.initials: X
authors.lastname: Xiong
mesh_terms: D001699:Biometry / Q000379:methods*; D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods*; D004311:Double-Blind Method; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D016013:Likelihood Functions; D015233:Models, Statistical; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor