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Estimating Incidence Rate on Current Status Data with Application to a Phase IV Cancer Trial
Authors:Shesh N Rai  Jianmin Pan  Xiaobin Yuan  Jianguo Sun  Melissa M Hudson  Deo K Srivastava
Institution:1. Biostatistics Shared Facility, JG Brown Cancer Center and Department of Bioinformatics and Biostatistics , University of Louisville , Louisville , Kentucky , USA Shesh.Rai@Loisville.Edu;3. Biostatistics Shared Facility, JG Brown Cancer Center and Department of Bioinformatics and Biostatistics , University of Louisville , Louisville , Kentucky , USA;4. Department of Statistics , University of Missouri-Columbia , Columbia , Missouri , USA;5. St. Jude Children's Research Hospital , Memphis , Tennessee , USA
Abstract:New drug discovery in the pediatrics has dramatically improved survival, but with long- term adverse events. This motivates the examination of adverse outcomes such as long-term toxicity in a phase IV trial. An ideal approach to monitor long-term toxicity is to systematically follow the survivors, which is generally not feasible. Instead, cross-sectional surveys are conducted in Hudson et al. (2007 Hudson , M. M. , Rai , S. N. , Nunez , C. , Merchant , T. E. , Marina , N. M. , Zalamea , N. , Cox , C. , Phipps , S. , Pompeu , R. , Rosenthal , D. ( 2007 ). Noninvasive evaluation of late anthracycline cardiac toxicity in childhood cancer survivors . J. Clin. Oncol. 25 : 36353643 .Crossref], PubMed], Web of Science ®] Google Scholar]), with one of the objectives to estimate the cumulative incidence rates along with specific interest in fixed-term (5 or 10 year) rates. We present inference procedures based on current status data to our motivating example with very interesting findings.
Keywords:Cardiotoxicity  Cross-section survey data  Interval censored data  K-M method  Phase IV clinical trial
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