Estimating Incidence Rate on Current Status Data with Application to a Phase IV Cancer Trial |
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Authors: | Shesh N Rai Jianmin Pan Xiaobin Yuan Jianguo Sun Melissa M Hudson Deo K Srivastava |
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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 |
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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 : 3635 – 3643 .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. |
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Keywords: | Cardiotoxicity Cross-section survey data Interval censored data K-M method Phase IV clinical trial |
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