title: A proposed approach for analyzing post-study therapy effect in survival analysis.
abstract: Clinical trials that explore long-term endpoints may confound the analysis when post-study therapy effects are considered. This article introduces a procedure to mediate the effects of confounding and allow inferences of first-line experimental treatments in the presence of post-study therapy. The procedure is evaluated by intensive simulation analyses and applied to an analysis of a clinical cancer trial.
authors.affiliation: a Celgene Corporation , Berkeley Heights , New Jersey , USA.
authors.forename: Xiaolong
authors.initials: X
authors.lastname: Luo
authors.affiliation: a Celgene Corporation , Berkeley Heights , New Jersey , USA.
authors.forename: Mingyu
authors.initials: M
authors.lastname: Li
authors.affiliation: a Celgene Corporation , Berkeley Heights , New Jersey , USA.
authors.forename: Chengqing
authors.initials: C
authors.lastname: Wu
authors.affiliation: a Celgene Corporation , Berkeley Heights , New Jersey , USA.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Xu
authors.affiliation: a Celgene Corporation , Berkeley Heights , New Jersey , USA.
authors.forename: Guang
authors.initials: G
authors.lastname: Chen
authors.affiliation: a Celgene Corporation , Berkeley Heights , New Jersey , USA.
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Dornseif
authors.affiliation: a Celgene Corporation , Berkeley Heights , New Jersey , USA.
authors.forename: Markus F
authors.initials: MF
authors.lastname: Renschler
authors.affiliation: b Gillings School of Global Public Health , University of North Carolina at Chapel Hill , Chapel Hill , North Carolina , USA.
authors.forename: Gary
authors.initials: G
authors.lastname: Koch
mesh_terms: D002986:Clinical Trials as Topic; D015986:Confounding Factors, Epidemiologic; D003627:Data Interpretation, Statistical; D006801:Humans; D009369:Neoplasms / Q000628:therapy; D016019:Survival Analysis
keywords: Cancer trial; crossover; survival analysis