Publications

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Endpoint Determination
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.
Chen, Ming-Hui, Joseph G. Ibrahim, Arvind K. Shah, Jianxin Lin, and Hui Yao. "Meta-analysis methods and models with applications in evaluation of cholesterol-lowering drugs." Stat Med 31, no. 28 (2012): 3597-616.
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.
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.
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.
Zhang, Min, Anastasios A. Tsiatis, Marie Davidian, Karen S. Pieper, and Kenneth W. Mahaffey. "Inference on treatment effects from a randomized clinical trial in the presence of premature treatment discontinuation: the SYNERGY trial." Biostatistics 12, no. 2 (2011): 258-69.
Jung, Sin-Ho, Sang Ah Chi, and Hyun Joo Ahn. "K-Sample comparisons using propensity analysis." Biom J 61, no. 3 (2019): 698-713.
Jung, Sin-Ho. "Phase II cancer clinical trials for biomarker-guided treatments." J Biopharm Stat 28, no. 2 (2018): 256-263.
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. "Flexible stopping boundaries when changing primary endpoints after unblinded interim analyses." J Biopharm Stat 24, no. 4 (2014): 817-33.
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.
Wang, Xiaofei, Jingzhu Zhou, Ting Wang, and Stephen L. George. "On Enrichment Strategies for Biomarker Stratified Clinical Trials." J Biopharm Stat 28, no. 2 (2018): 292-308.
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.
Drugs, Investigational
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.
Double-Blind Method
Harbeck, Nadia, Oleg Lipatov, Mona Frolova, Dmitry Udovitsa, Eldar Topuzov, Doina Elena Ganea-Motan, Roumen Nakov, Pritibha Singh, Anita Rudy, and Kimberly Blackwell. "Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer." Future Oncol 12, no. 11 (2016): 1359-67.
Blackwell, Kimberly, Roman Donskih, Michael C Jones, Allen Nixon, Maria J. Vidal, Roumen Nakov, Pritibha Singh, Gregor Schaffar, Pere Gascón, and Nadia Harbeck. "A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supp." Oncologist 21, no. 7 (2016): 789-94.
Zeng, Donglin, Joseph G. Ibrahim, Ming-Hui Chen, Kuolung Hu, and Catherine Jia. "Multivariate recurrent events in the presence of multivariate informative censoring with applications to bleeding and transfusion events in myelodysplastic syndrome." J Biopharm Stat 24, no. 2 (2014): 429-42.
McClure, Robert K., Martin Styner, Eric Maltbie, Jeffrey A. Lieberman, Sylvain Gouttard, Guido Gerig, Xiaoyan Shi, and Hongtu Zhu. "Localized differences in caudate and hippocampal shape are associated with schizophrenia but not antipsychotic type." Psychiatry Res 211, no. 1 (2013): 1-10.
Secord, Angeles Alvarez, Kirsten Bell Burdett, Kouros Owzar, David Tritchler, Alexander B. Sibley, Yingmiao Liu, Mark D. Starr, Chris J Brady, Heather A. Lankes, Herbert I. Hurwitz et al. "Predictive Blood-Based Biomarkers in Patients with Epithelial Ovarian Cancer Treated with Carboplatin and Paclitaxel with or without Bevacizumab: Results from GOG-0218." Clin Cancer Res 26, no. 6 (2020): 1288-1296.
Dose-Response Relationship, Drug
Jia, Xiaoyu, Anastasia Ivanova, and Shing M. Lee. "Selection of the initial design for the two-stage continual reassessment method." J Biopharm Stat 27, no. 3 (2017): 495-506.
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.
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.
Li, Xiang, Anastasia Ivanova, Hong Tian, Pilar Lim, and Kevin Liu. "Continual reassessment method with regularization in phase I clinical trials." J Biopharm Stat 30, no. 6 (2020): 964-978.
Wages, Nolan A., Anastasia Ivanova, and Olga Marchenko. "Practical designs for Phase I combination studies in oncology." J Biopharm Stat 26, no. 1 (2016): 150-66.
Chiuzan, Cody, Jonathan Shtaynberger, Gulam A. Manji, Jimmy K. Duong, Gary K. Schwartz, Anastasia Ivanova, and Shing M. Lee. "Dose-finding designs for trials of molecularly targeted agents and immunotherapies." J Biopharm Stat 27, no. 3 (2017): 477-494.
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.
Bayar, Mohamed Amine, Anastasia Ivanova, and Gwenael Le Teuff. "CRM2DIM: A SAS macro for implementing the dual-agent Bayesian continual reassessment method." Comput Methods Programs Biomed 176 (2019): 211-223.
Ivanova, Anastasia, Yunfei Wang, and Matthew C. Foster. "The rapid enrollment design for Phase I clinical trials." Stat Med 35, no. 15 (2016): 2516-24.

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