Publications

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Clinical Trials as Topic
Sargent, Daniel J., and Stephen L. George. "Clinical trials data collection: when less is more." J Clin Oncol 28, no. 34 (2010): 5019-21.
Zhao, Yufan, Donglin Zeng, Mark A. Socinski, and Michael R. Kosorok. "Reinforcement learning strategies for clinical trials in nonsmall cell lung cancer." Biometrics 67, no. 4 (2011): 1422-33.
Zhang, Baqun, Anastasios A. Tsiatis, Eric B. Laber, and Marie Davidian. "A robust method for estimating optimal treatment regimes." Biometrics 68, no. 4 (2012): 1010-8.
Kim, Sungduk, Ming-Hui Chen, Joseph G. Ibrahim, Arvind K. Shah, and Jianxin Lin. "Bayesian inference for multivariate meta-analysis Box-Cox transformation models for individual patient data with applications to evaluation of cholesterol-lowering drugs." Stat Med 32, no. 23 (2013): 3972-90.
Chen, Ming-Hui, Joseph G. Ibrahim, Peter Lam, Alan Yu, and Yuanye Zhang. "Bayesian design of noninferiority trials for medical devices using historical data." Biometrics 67, no. 3 (2011): 1163-70.
Owzar, Kouros, William T. Barry, and Sin-Ho Jung. "Statistical considerations for analysis of microarray experiments." Clin Transl Sci 4, no. 6 (2011): 466-77.
Ibrahim, Joseph G., Haitao Chu, and Ming-Hui Chen. "Missing data in clinical studies: issues and methods." J Clin Oncol 30, no. 26 (2012): 3297-303.
Ibrahim, Joseph G., Ming-Hui Chen, and Haitao Chu. "Bayesian methods in clinical trials: a Bayesian analysis of ECOG trials E1684 and E1690." BMC Med Res Methodol 12 (2012): 183.
Jung, Sin-Ho. "Stratified Fisher's exact test and its sample size calculation." Biom J 56, no. 1 (2014): 129-40.
Laber, Eric B., Daniel J. Lizotte, and Bradley Ferguson. "Set-valued dynamic treatment regimes for competing outcomes." Biometrics 70, no. 1 (2014): 53-61.
Viele, Kert, Scott Berry, Beat Neuenschwander, Billy Amzal, Fang Chen, Nathan Enas, Brian Hobbs, Joseph G. Ibrahim, Nelson Kinnersley, Stacy Lindborg et al. "Use of historical control data for assessing treatment effects in clinical trials." Pharm Stat 13, no. 1 (2014): 41-54.
Daniel, Rhian M., and Anastasios A. Tsiatis. "Efficient estimation of the distribution of time to composite endpoint when some endpoints are only partially observed." Lifetime Data Anal 19, no. 4 (2013): 513-46.
Chen, Liddy M., Joseph G. Ibrahim, and Haitao Chu. "Flexible stopping boundaries when changing primary endpoints after unblinded interim analyses." J Biopharm Stat 24, no. 4 (2014): 817-33.
Chen, Ming-Hui, Joseph G. Ibrahim, Donglin Zeng, Kuolung Hu, and Catherine Jia. "Bayesian design of superiority clinical trials for recurrent events data with applications to bleeding and transfusion events in myelodyplastic syndrome." Biometrics 70, no. 4 (2014): 1003-13.
Geng, Yuan, Hao Helen Zhang, and Wenbin Lu. "On optimal treatment regimes selection for mean survival time." Stat Med 34, no. 7 (2015): 1169-84.
Zeng, Donglin, Ming-Hui Chen, Joseph G. Ibrahim, Rachel Wei, Beiying Ding, Chunlei Ke, and Qi Jiang. "A counterfactual p-value approach for benefit-risk assessment in clinical trials." J Biopharm Stat 25, no. 3 (2015): 508-24.
Zeng, Donglin, Emil Cornea, Jun Dong, Jean Pan, and Joseph G. Ibrahim. "Assessing temporal agreement between central and local progression-free survival times." Stat Med 34, no. 5 (2015): 844-58.
Ibrahim, Joseph G., Haitao Chu, and Liddy M. Chen. "Basic concepts and methods for joint models of longitudinal and survival data." J Clin Oncol 28, no. 16 (2010): 2796-801.
Zhang, Baqun, Anastasios A. Tsiatis, Eric B. Laber, and Marie Davidian. "Response to reader reaction." Biometrics 71, no. 1 (2015): 267-273.
Zhang, Yichi, Eric B. Laber, Anastasios Tsiatis, and Marie Davidian. "Using decision lists to construct interpretable and parsimonious treatment regimes." Biometrics 71, no. 4 (2015): 895-904.
Ibrahim, Joseph G., Ming-Hui Chen, Yeongjin Gwon, and Fang Chen. "The power prior: theory and applications." Stat Med 34, no. 28 (2015): 3724-49.
Kong, Dehan, Arnab Maity, Fang-Chi Hsu, and Jung-Ying Tzeng. "Testing and estimation in marker-set association study using semiparametric quantile regression kernel machine." Biometrics 72, no. 2 (2016): 364-71.
Zhang, Danjie, Ming-Hui Chen, Joseph G. Ibrahim, Mark E. Boye, Ping Wang, and Wei Shen. "Assessing model fit in joint models of longitudinal and survival data with applications to cancer clinical trials." Stat Med 33, no. 27 (2014): 4715-33.
A Gould, Lawrence, Mark Ernest Boye, Michael J. Crowther, Joseph G. Ibrahim, George Quartey, Sandrine Micallef, and Frederic Y. Bois. "Joint modeling of survival and longitudinal non-survival data: current methods and issues. Report of the DIA Bayesian joint modeling working group." Stat Med 34, no. 14 (2015): 2181-95.
A Gould, Lawrence, Mark Ernest Boye, Michael J. Crowther, Joseph G. Ibrahim, George Quartey, Sandrine Micallef, and Frederic Y. Bois. "Responses to discussants of 'Joint modeling of survival and longitudinal non-survival data: current methods and issues. report of the DIA Bayesian joint modeling working group'." Stat Med 34, no. 14 (2015): 2202-3.
Foster, Nathan R., Lindsay A. Renfro, Steven E. Schild, Mary W. Redman, Xiaofei F. Wang, Suzanne E. Dahlberg, Keyue Ding, Penelope A. Bradbury, Suresh S. Ramalingam, David R. Gandara et al. "Multitrial Evaluation of Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Extensive-Stage Small-Cell Lung Cancer." J Thorac Oncol 10, no. 7 (2015): 1099-106.
Zhao, Yue, Amy H. Herring, Haibo Zhou, Mirza W. Ali, and Gary G. Koch. "A multiple imputation method for sensitivity analyses of time-to-event data with possibly informative censoring." J Biopharm Stat 24, no. 2 (2014): 229-53.
Pang, Herbert, and Xiaofei Wang. "Statistical aspect of translational and correlative studies in clinical trials." Chin Clin Oncol 5, no. 1 (2016): 11.
Pang, Herbert H., Xiaofei Wang, Thomas E. Stinchcombe, Melisa L. Wong, Perry Cheng, Apar Kishor Ganti, Daniel J. Sargent, Ying Zhang, Chen Hu, Sumithra J. Mandrekar et al. "Enrollment Trends and Disparity Among Patients With Lung Cancer in National Clinical Trials, 1990 to 2012." J Clin Oncol 34, no. 33 (2016): 3992-3999.
Kang, Suhyun, Wenbin Lu, and Rui Song. "Subgroup detection and sample size calculation with proportional hazards regression for survival data." Stat Med 36, no. 29 (2017): 4646-4659.
Psioda, Matthew A., and Joseph G. Ibrahim. "Bayesian clinical trial design using historical data that inform the treatment effect." Biostatistics 20, no. 3 (2019): 400-415.
Ibrahim, Joseph G., Sungduk Kim, Ming-Hui Chen, Arvind K. Shah, and Jianxin Lin. "Bayesian multivariate skew meta-regression models for individual patient data." Stat Methods Med Res 28, no. 10-11 (2019): 3415-3436.
Psioda, Matthew A., Mat Soukup, and Joseph G. Ibrahim. "A practical Bayesian adaptive design incorporating data from historical controls." Stat Med 37, no. 27 (2018): 4054-4070.
Schild, Steven E., Wen Fan, Thomas E. Stinchcombe, Everett E. Vokes, Suresh S. Ramalingam, Jeffrey D. Bradley, Karen Kelly, Herbert H. Pang, and Xiaofei Wang. "Toxicity Related to Radiotherapy Dose and Targeting Strategy: A Pooled Analysis of Cooperative Group Trials of Combined Modality Therapy for Locally Advanced Non-Small Cell Lung Cancer." J Thorac Oncol 14, no. 2 (2019): 298-303.
Diao, Guoqing, Guanghan F. Liu, Donglin Zeng, William Wang, Xianming Tan, Joseph F. Heyse, and Joseph G. Ibrahim. "Efficient methods for signal detection from correlated adverse events in clinical trials." Biometrics 75, no. 3 (2019): 1000-1008.
Rashid, Naim U., Xianlu L. Peng, Chong Jin, Richard A. Moffitt, Keith E. Volmar, Brian A. Belt, Roheena Z. Panni, Timothy M. Nywening, Silvia G. Herrera, Kristin J. Moore et al. "Purity Independent Subtyping of Tumors (PurIST), A Clinically Robust, Single-sample Classifier for Tumor Subtyping in Pancreatic Cancer." Clin Cancer Res 26, no. 1 (2020): 82-92.
Psioda, Matthew A., Kuolung Hu, Yang Zhang, Jean Pan, and Joseph G. Ibrahim. "Bayesian design of biosimilars clinical programs involving multiple therapeutic indications." Biometrics 76, no. 2 (2020): 630-642.
Xue, Xiaoqiang, Matthew C. Foster, and Anastasia Ivanova. "Rapid enrollment design for finding the optimal dose in immunotherapy trials with ordered groups." J Biopharm Stat 29, no. 4 (2019): 625-634.
Joshi, Neha, Jason Fine, Rong Chu, and Anastasia Ivanova. "Estimating the subgroup and testing for treatment effect in a post-hoc analysis of a clinical trial with a biomarker." J Biopharm Stat 29, no. 4 (2019): 685-695.
Clinical Trials, Phase II as Topic
Ibrahim, Joseph G., Ming-Hui Chen, Amy H Xia, and Thomas Liu. "Bayesian meta-experimental design: evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes." Biometrics 68, no. 2 (2012): 578-86.
Jung, Sin-Ho, Myron N. Chang, and Sun J. Kang. "Phase II cancer clinical trials with heterogeneous patient populations." J Biopharm Stat 22, no. 2 (2012): 312-28.
Chen, Ming-Hui, Joseph G. Ibrahim, Amy H Xia, Thomas Liu, and Violeta Hennessey. "Bayesian sequential meta-analysis design in evaluating cardiovascular risk in a new antidiabetic drug development program." Stat Med 33, no. 9 (2014): 1600-18.
Kwak, Minjung, and Sin-Ho Jung. "Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test." Stat Med 33, no. 12 (2014): 2004-16.
Jung, Sin-Ho, and Daniel J. Sargent. "Randomized phase II clinical trials." J Biopharm Stat 24, no. 4 (2014): 802-16.
Jung, Sin-Ho. "Statistical issues for design and analysis of single-arm multi-stage phase II cancer clinical trials." Contemp Clin Trials 42 (2015): 9-17.
Zeng, Donglin, Emil Cornea, Jun Dong, Jean Pan, and Joseph G. Ibrahim. "Assessing temporal agreement between central and local progression-free survival times." Stat Med 34, no. 5 (2015): 844-58.
Zeng, Donglin, Fei Gao, Kuolung Hu, Catherine Jia, and Joseph G. Ibrahim. "Hypothesis testing for two-stage designs with over or under enrollment." Stat Med 34, no. 16 (2015): 2417-26.
Ibrahim, Joseph G., Ming-Hui Chen, Mani Lakshminarayanan, Guanghan F. Liu, and Joseph F. Heyse. "Bayesian probability of success for clinical trials using historical data." Stat Med 34, no. 2 (2015): 249-64.
Barry, William T., Charles M. Perou, Kelly P Marcom, Lisa A. Carey, and Joseph G. Ibrahim. "The use of Bayesian hierarchical models for adaptive randomization in biomarker-driven phase II studies." J Biopharm Stat 25, no. 1 (2015): 66-88.
Song, Guochen, and Anastasia Ivanova. "Enrollment and Stopping Rules for Managing Toxicity Requiring Long Follow-Up in Phase II Oncology Trials." J Biopharm Stat 25, no. 6 (2015): 1206-14.
Foster, Nathan R., Lindsay A. Renfro, Steven E. Schild, Mary W. Redman, Xiaofei F. Wang, Suzanne E. Dahlberg, Keyue Ding, Penelope A. Bradbury, Suresh S. Ramalingam, David R. Gandara et al. "Multitrial Evaluation of Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Extensive-Stage Small-Cell Lung Cancer." J Thorac Oncol 10, no. 7 (2015): 1099-106.
Yuan, Jiacheng, Herbert Pang, Tiejun Tong, Dong Xi, Wenzhao Guo, and Peter Mesenbrink. "Seamless Phase IIa/IIb and enhanced dose-finding adaptive design." J Biopharm Stat 26, no. 5 (2016): 912-23.
Kwak, Minjung, and Sin-Ho Jung. "Optimal two-stage log-rank test for randomized phase II clinical trials." J Biopharm Stat 27, no. 4 (2017): 639-658.
Parke, Tom, Olga Marchenko, Vladimir Anisimov, Anastasia Ivanova, Christopher Jennison, Inna Perevozskaya, and Guochen Song. "Comparing oncology clinical programs by use of innovative designs and expected net present value optimization: Which adaptive approach leads to the best result?" J Biopharm Stat 27, no. 3 (2017): 457-476.
Stinchcombe, Thomas E., Ying Zhang, Everett E. Vokes, Joan H. Schiller, Jeffrey D. Bradley, Karen Kelly, Walter J. Curran, Steven E. Schild, Benjamin Movsas, Gerald Clamon et al. "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, no. 25 (2017): 2885-2892.
Jung, Sin-Ho. "Phase II cancer clinical trials for biomarker-guided treatments." J Biopharm Stat 28, no. 2 (2018): 256-263.
Ivanova, Anastasia, Barry Paul, Olga Marchenko, Guochen Song, Neerali Patel, and Stergios J. Moschos. "Nine-year change in statistical design, profile, and success rates of Phase II oncology trials." J Biopharm Stat 26, no. 1 (2016): 141-9.
Hamy, Anne-Sophie, Sandrine Tury, Xiaofei Wang, Junheng Gao, Jean-Yves Pierga, Sylvie Giacchetti, Etienne Brain, Barbara Pistilli, Michel Marty, Marc Espié et al. "Celecoxib With Neoadjuvant Chemotherapy for Breast Cancer Might Worsen Outcomes Differentially by COX-2 Expression and ER Status: Exploratory Analysis of the REMAGUS02 Trial." J Clin Oncol 37, no. 8 (2019): 624-635.
Cao, Xiaowen, Apar Kishor Ganti, Thomas Stinchcombe, Melisa L. Wong, James C. Ho, Chen Shen, Yingzhou Liu, Jeffery Crawford, Herbert Pang, and Xiaofei Wang. "Predicting risk of chemotherapy-induced severe neutropenia: A pooled analysis in individual patients data with advanced lung cancer." Lung Cancer 141 (2020): 14-20.
Clinical Trials, Phase III as Topic
Michiels, Stefan, Richard F. Potthoff, and Stephen L. George. "Multiple testing of treatment-effect-modifying biomarkers in a randomized clinical trial with a survival endpoint." Stat Med 30, no. 13 (2011): 1502-18.
Chen, Liddy M., Joseph G. Ibrahim, and Haitao Chu. "Sample size and power determination in joint modeling of longitudinal and survival data." Stat Med 30, no. 18 (2011): 2295-309.
Ibrahim, Joseph G., Ming-Hui Chen, Amy H Xia, and Thomas Liu. "Bayesian meta-experimental design: evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes." Biometrics 68, no. 2 (2012): 578-86.
Wang, Xiaofei, Junling Ma, and Stephen L. George. "ROC curve estimation under test-result-dependent sampling." Biostatistics 14, no. 1 (2013): 160-72.
Sanoff, Hanna K., William R. Carpenter, Christopher F. Martin, Daniel J. Sargent, Jeffrey A. Meyerhardt, Til Stürmer, Jason P. Fine, Jane Weeks, Joyce Niland, Katherine L. Kahn et al. "Comparative effectiveness of oxaliplatin vs non-oxaliplatin-containing adjuvant chemotherapy for stage III colon cancer." J Natl Cancer Inst 104, no. 3 (2012): 211-27.
Chen, Ming-Hui, Joseph G. Ibrahim, Amy H Xia, Thomas Liu, and Violeta Hennessey. "Bayesian sequential meta-analysis design in evaluating cardiovascular risk in a new antidiabetic drug development program." Stat Med 33, no. 9 (2014): 1600-18.
Potthoff, Richard F., and Susan Halabi. "A novel test to compare two treatments based on endpoints involving both nonfatal and fatal events." Pharm Stat 14, no. 4 (2015): 273-83.
Zhang, Danjie, Ming-Hui Chen, Joseph G. Ibrahim, Mark E. Boye, Ping Wang, and Wei Shen. "Assessing model fit in joint models of longitudinal and survival data with applications to cancer clinical trials." Stat Med 33, no. 27 (2014): 4715-33.
Ibrahim, Joseph G., Ming-Hui Chen, Mani Lakshminarayanan, Guanghan F. Liu, and Joseph F. Heyse. "Bayesian probability of success for clinical trials using historical data." Stat Med 34, no. 2 (2015): 249-64.
Foster, Nathan R., Lindsay A. Renfro, Steven E. Schild, Mary W. Redman, Xiaofei F. Wang, Suzanne E. Dahlberg, Keyue Ding, Penelope A. Bradbury, Suresh S. Ramalingam, David R. Gandara et al. "Multitrial Evaluation of Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Extensive-Stage Small-Cell Lung Cancer." J Thorac Oncol 10, no. 7 (2015): 1099-106.
Parke, Tom, Olga Marchenko, Vladimir Anisimov, Anastasia Ivanova, Christopher Jennison, Inna Perevozskaya, and Guochen Song. "Comparing oncology clinical programs by use of innovative designs and expected net present value optimization: Which adaptive approach leads to the best result?" J Biopharm Stat 27, no. 3 (2017): 457-476.
Stinchcombe, Thomas E., Ying Zhang, Everett E. Vokes, Joan H. Schiller, Jeffrey D. Bradley, Karen Kelly, Walter J. Curran, Steven E. Schild, Benjamin Movsas, Gerald Clamon et al. "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, no. 25 (2017): 2885-2892.
Gao, Fei, Jun Dong, Donglin Zeng, Alan Rong, and Joseph G. Ibrahim. "Pattern mixture models for clinical validation of biomarkers in the presence of missing data." Stat Med 36, no. 19 (2017): 2994-3004.
Diao, Guoqing, Jun Dong, Donglin Zeng, Chunlei Ke, Alan Rong, and Joseph G. Ibrahim. "Biomarker threshold adaptive designs for survival endpoints." J Biopharm Stat 28, no. 6 (2018): 1038-1054.
Deng, Qiqi, Ying-Ying Zhang, Dooti Roy, and Ming-Hui Chen. "Superiority of combining two independent trials in interim futility analysis." Stat Methods Med Res 29, no. 2 (2020): 522-540.
Cao, Xiaowen, Apar Kishor Ganti, Thomas Stinchcombe, Melisa L. Wong, James C. Ho, Chen Shen, Yingzhou Liu, Jeffery Crawford, Herbert Pang, and Xiaofei Wang. "Predicting risk of chemotherapy-induced severe neutropenia: A pooled analysis in individual patients data with advanced lung cancer." Lung Cancer 141 (2020): 14-20.
Cluster Analysis
Cai, Jianwen, and Donglin Zeng. "Additive mixed effect model for clustered failure time data." Biometrics 67, no. 4 (2011): 1340-51.
Kang, Chaeryon, Bahjat Qaqish, Jane Monaco, Stacey L. Sheridan, and Jianwen Cai. "Kappa statistic for clustered dichotomous responses from physicians and patients." Stat Med 32, no. 21 (2013): 3700-19.
Chen, Guanhua, Patrick F. Sullivan, and Michael R. Kosorok. "Biclustering with heterogeneous variance." Proc Natl Acad Sci U S A 110, no. 30 (2013): 12253-8.
Reich, Brian J., and Howard D. Bondell. "A spatial dirichlet process mixture model for clustering population genetics data." Biometrics 67, no. 2 (2011): 381-90.
Lee, Mei-Hsien, Jung-Ying Tzeng, Su-Yun Huang, and Chuhsing Kate Hsiao. "Combining an evolution-guided clustering algorithm and haplotype-based LRT in family association studies." BMC Genet 12 (2011): 48.
Skup, Martha, Hongtu Zhu, Yaping Wang, Kelly S. Giovanello, Ja-an Lin, Dinggang Shen, Feng Shi, Wei Gao, Weili Lin, Yong Fan et al. "Sex differences in grey matter atrophy patterns among AD and aMCI patients: results from ADNI." Neuroimage 56, no. 3 (2011): 890-906.
Silva, Grace O., Marni B. Siegel, Lisle E. Mose, Joel S. Parker, Wei Sun, Charles M. Perou, and Mengjie Chen. "SynthEx: a synthetic-normal-based DNA sequencing tool for copy number alteration detection and tumor heterogeneity profiling." Genome Biol 18, no. 1 (2017): 66.
Deng, Yu, Donglin Zeng, Jinying Zhao, and Jianwen Cai. "Proportional hazards model with a change point for clustered event data." Biometrics 73, no. 3 (2017): 835-845.

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