Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics

Part I. Biomarker and Personalized Medicine

1. Optimal Biomarker-Guided Design for Targeted Therapy with Imperfectly Measured Biomarkers
Yong Zang, Ying Yuan

2. Statistical Considerations for Evaluating Prognostic Biomarkers: Choosing Optimal Threshold
Zheng Zhang

3. Accuracy of Meta-Analysis Using Different Levels of Diagnostic Accuracy Measures
Yanyan Song, Ying Lu, Lu Tian

Part II. Bayesian Methods and Applications

4. Bayesian Frailty Models for Multi-State Survival Data
Mário Castro, Ming-Hui Chen, Yuanye Zhang

5. Bayesian Integration of In Vitro Biomarker to Analysis of In Vivo Safety Assessment
Ming-Dauh Wang, Alan Y. Chiang

6. A Phase II Trial Design with Bayesian Adaptive Covariate-Adjusted Randomization
Jianchang Lin, Li-An Lin, Serap Sankoh

Part III. Dose Ranging Studies in Clinical Trials

7. Sample Size Allocation in a Dose-Ranging Trial Combined with PoC
Qiqi Deng, Naitee Ting

8. Personalized Effective Dose Selection in Dose Ranging Studies
Xiwen Ma, Wei Zheng, Yuefeng Lu

Part IV. Innovative Clinical Trial Designs and Analysis

9. Evaluation of Consistency Requirements in Multi-Regional Clinical Trials with Different Endpoints
Zhaoyang Teng, Jianchang Lin, Bin Zhang

10. A Statistical Decision Framework Applicable to Multipopulation Tailoring Trials
Brian A. Millen

11. Assessing Benefit and Consistency of Treatment Effect Under a Discrete Random Effects Model in Multiregional Clinical Trials
Jung-Tzu Liu, Chi-Tian Chen, K. K. Gordon Lan, Chyng-Shyan Tzeng, Chin-Fu Hsiao, Hsiao-Hui Tsou

12. Design and Analysis of Multiregional Clinical Trials in Evaluation of Medical Devices: A Two-Component Bayesian Approach for Targeted Decision Making
Yunling Xu, Nelson Lu, Ying Yang

13. Semiparametric Analysis of Interval-Censored Survival Data with Median Regression Model
Jianchang Lin, Debajyoti Sinha, Stuart Lipsitz, Adriano Polpo

14. Explained Variation for Correlated Survival Data Under the Proportional Hazards Mixed-Effects Model
Gordon Honerkamp-Smith, Ronghui Xu

15. Some Misconceptions on the Use of Composite Endpoints
Jianjun (David) Li, Jin Xu

Part V. Clinical and Safety Monitoring in Clinical Trials

16. A Statistical Model for Risk-Based Monitoring of Clinical Trials
Gregory J. Hather

17. Blinded Safety Signal Monitoring for the FDA IND Reporting Final Rule
Greg Ball, Patrick M. Schnell

Part VI. Statistical Applications in Nonclinical and Preclinical Drug Development

18. Design and Statistical Analysis of Multidrug Combinations in Preclinical Studies and Phase I Clinical Trials
Ming T. Tan, Hong-Bin Fang, Hengzhen Huang, Yang Yang

19. Statistical Methods for Analytical Comparability
Leslie Sidor

20. Statistical Applications for Biosimilar Product Development
Richard Montes, Bryan Bernat, Catherine Srebalus-Barnes

Part VII. Statistical Learning Methods and Applications with Large-scale Data

21. A Statistical Method for Change-Set Analysis
Pei-Sheng Lin, Jun Zhu, Shu-Fu Kuo, Katherine Curtis

22. An Alarm System for Flu Outbreaks Using Google Flu Trend Data
Gregory Vaughan, Robert Aseltine, Sy Han Chiou, Jun Yan

23. Identifying Gene-Environment Interactions with a Least Relative Error Approach
Yangguang Zang, Yinjun Zhao, Qingzhao Zhang, Hao Chai, Sanguo Zhang, Shuangge Ma

24. Partially Supervised Sparse Factor Regression For Multi-Class Classification
Chongliang Luo, Dipak Dey, Kun Chen

Part VIII. Statistical Applications in Business and Finance

25. A Bivariate Random-Effects Copula Model for Length of Stay and Cost
Xiaoqin Tang, Zhehui Luo, Joseph C. Gardiner

Avainsanat: Statistics, Statistics for Life Sciences, Medicine, Health Sciences, Statistical Theory and Methods, Biostatistics, Probability and Statistics in Computer Science