The Sentinel Initiative mandated by the Food and Drug Administration will lead to an enormous number of studies being planned post-market that will require analyzing and combining data from several different studies. The proposed project will address this challenge through developing new and flexible methods for meta-analysis using a variety of models, including models for binary and discrete data, models for longitudinal data, and models for time-to-event data. A related issue that will also be addressed is design, sample size, and power considerations using these types of meta-analytic models. Such models and data collected post-market can be quite useful in designing future clinical studies such as non-inferiority, equivalence, and superiority cancer clinical trials. The proposed project will also develop methods for metaanalytic studies of diagnostic tests to facilitate evidence-based medicine. We will also create flexible and robust methodology for accurately comparing rare adverse event rates in cancer for different drugs and for determining how those rates are affected by important prognostic factors. The proposed project will also explore statistical methods for the analysis of large cancer data sets for calibrating treatment dose in the presence of potentially conflicting factors, such as length and quality of life and economic costs. We will explore these tradeoffs rigorously, using a utility based approach traditionally employed in the analysis of health policy at the population level. The proposed statistical methodology will be broadly applicable to complex, large scale, data sets arising in phase III clinical trials and post-marketing studies.
The proposed statistical methodology will be broadly applicable to the statistical analysis and interpretation of complex, large scale, data sets arising in phase III clinical trials and post-marketing studies. The research will improve public health be facilitating discovery of important benefits and risks of cancer treatment.
|Wang, Xiaofei; Wang, Xiaoyi; Hodgson, Lydia et al. (2017) Validation of Progression-Free Survival as a Surrogate Endpoint for Overall Survival in Malignant Mesothelioma: Analysis of Cancer and Leukemia Group B and North Central Cancer Treatment Group (Alliance) Trials. Oncologist 22:189-198|
|Zhang, Danjie; Chen, Ming-Hui; Ibrahim, Joseph G et al. (2017) Bayesian Model Assessment in Joint Modeling of Longitudinal and Survival Data with Applications to Cancer Clinical Trials. J Comput Graph Stat 26:121-133|
|Kang, Suhyun; Lu, Wenbin; Song, Rui (2017) Subgroup detection and sample size calculation with proportional hazards regression for survival data. Stat Med 36:4646-4659|
|Zhao, Jingkang; Li, Dongshunyi; Seo, Jungkyun et al. (2017) Quantifying the Impact of Non-coding Variants on Transcription Factor-DNA Binding. Res Comput Mol Biol 10229:336-352|
|Silva, Grace O; Siegel, Marni B; Mose, Lisle E et al. (2017) SynthEx: a synthetic-normal-based DNA sequencing tool for copy number alteration detection and tumor heterogeneity profiling. Genome Biol 18:66|
|Stinchcombe, Thomas E; Zhang, Ying; Vokes, Everett E et al. (2017) Pooled Analysis of Individual Patient Data on Concurrent Chemoradiotherapy for Stage III Non-Small-Cell Lung Cancer in Elderly Patients Compared With Younger Patients Who Participated in US National Cancer Institute Cooperative Group Studies. J Clin Oncol 35:2885-2892|
|Li, Zhiguo (2017) Comparison of adaptive treatment strategies based on longitudinal outcomes in sequential multiple assignment randomized trials. Stat Med 36:403-415|
|Ding, Jieli; Lu, Tsui-Shan; Cai, Jianwen et al. (2017) Recent progresses in outcome-dependent sampling with failure time data. Lifetime Data Anal 23:57-82|
|Liang, Baosheng; Tong, Xingwei; Zeng, Donglin et al. (2017) SEMIPARAMETRIC REGRESSION ANALYSIS OF REPEATED CURRENT STATUS DATA. Stat Sin 27:1079-1100|
|Kong, Dehan; Maity, Arnab; Hsu, Fang-Chi et al. (2017) Rejoinder to ""A note on testing and estimation in marker-set association study using semiparametric quantile regression kernel machine"". Biometrics :|
Showing the most recent 10 out of 462 publications