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

1. Front Matter

   Pages i-xv

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2. Biomarker and Personalized Medicine

   1. Front Matter

      Pages 1-1

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   2. Optimal Biomarker-Guided Design for Targeted Therapy with Imperfectly Measured Biomarkers

      • Yong Zang, Ying Yuan

      Pages 3-13

   3. Statistical Considerations for Evaluating Prognostic Biomarkers: Choosing Optimal Threshold

      • Zheng Zhang

      Pages 15-20

   4. Accuracy of Meta-Analysis Using Different Levels of Diagnostic Accuracy Measures

      • Yanyan Song, Ying Lu, Lu Tian

      Pages 21-33

3. Bayesian Methods and Applications

   1. Front Matter

      Pages 35-35

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   2. Bayesian Frailty Models for Multi-State Survival Data

      • Mário de Castro, Ming-Hui Chen, Yuanye Zhang

      Pages 37-48

   3. Bayesian Integration of In Vitro Biomarker to Analysis of In Vivo Safety Assessment

      • Ming-Dauh Wang, Alan Y. Chiang

      Pages 49-60

   4. A Phase II Trial Design with Bayesian Adaptive Covariate-Adjusted Randomization

      • Jianchang Lin, Li-An Lin, Serap Sankoh

      Pages 61-73

4. Dose Ranging Studies in Clinical Trials

   1. Front Matter

      Pages 75-75

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   2. Sample Size Allocation in a Dose-Ranging Trial Combined with PoC

      • Qiqi Deng, Naitee Ting

      Pages 77-90

   3. Personalized Effective Dose Selection in Dose Ranging Studies

      • Xiwen Ma, Wei Zheng, Yuefeng Lu

      Pages 91-104

5. Innovative Clinical Trial Designs and Analysis

   1. Front Matter

      Pages 105-105

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   2. Evaluation of Consistency Requirements in Multi-Regional Clinical Trials with Different Endpoints

      • Zhaoyang Teng, Jianchang Lin, Bin Zhang

      Pages 107-120

   3. A Statistical Decision Framework Applicable to Multipopulation Tailoring Trials

      • Brian A. Millen

      Pages 121-125

   4. 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

      Pages 127-136

   5. 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

      Pages 137-147

   6. Semiparametric Analysis of Interval-Censored Survival Data with Median Regression Model

      • Jianchang Lin, Debajyoti Sinha, Stuart Lipsitz, Adriano Polpo

      Pages 149-163

   7. Explained Variation for Correlated Survival Data Under the Proportional Hazards Mixed-Effects Model

      • Gordon Honerkamp-Smith, Ronghui Xu

      Pages 165-177

   8. Some Misconceptions on the Use of Composite Endpoints

      • Jianjun (David) Li, Jin Xu

      Pages 179-187

The papers in this volume represent a broad, applied swath of advanced contributions to the 2015 ICSA/Graybill Applied Statistics Symposium of the International Chinese Statistical Association, held at Colorado State University in Fort Collins.  The contributions cover topics that range from statistical applications in business and finance to applications in clinical trials and biomarker analysis.  Each papers was peer-reviewed by at least two referees and also by an editor.  The conference was attended by over 400 participants from academia, industry, and government agencies around the world, including from North America, Asia, and Europe.

• Bayesian statistics
• personalized medicine
• survival analysis
• adaptive designs
• statistical genetics
• non-clinical CMC statistical application
• diagnostic medicine
• clinical trials
• clinical trial design
• modeling
• data analysis
• clinical trial analysis
• model misspecification
• futility design
• applied statistics
• data mining
• high-dimensional data mining
• biomarker analysis
• business analytics
• finance

• Global Statistics, Takeda Pharmaceuticals, Cambridge, USA

  Jianchang Lin

• Biostatistics, Boehringer Ingelheim Pharmaceuticals, Ridgefield, USA

  Bushi Wang

• Colorado State University , Fort Collins, USA

  Xiaowen Hu

• University of Connecticut , Storrs, USA

  Kun Chen

• Global Statistics, Takeda Pharmaceuticals Global Statistics, Cambridge, USA

  Ray Liu

Jianchang Lin, Ph.D., is Principal Statistician at Takeda Pharmaceuticals, with extensive experience in oncology drug clinical development, including leading successful NDA/MAA submissions and worldwide drug approvals.  Dr. Lin’s research interests include Bayesian methodologies, survival analysis and Bayesian adaptive designs, and their application in clinical trials. 

Bushi Wang, Ph.D., is a biostatistician at Boehringer Ingelheim Pharmaceuticals, Inc.  He researches clinical trials across different therapeutic areas and different phases, largely focusing on late stage oncology and cardiovascular trials, supporting approval.  He is co-founder of the Multiple Comparison Procedures Society, a .U.S organization supporting the international MCP conferences. 

Xiaowen Hu, Ph.D., is Assistant Professor in the Department of Statistics, Colorado State University.  Her research interests include spatial analysis, time series analysis, Bayesian analysis, and statistical analysis in business and empirical finance. 

Kun Chen, Ph.D., is Assistant Professor in the Department of Statistics, University of Connecticut.  His research interests include multivariate analysis, dimension reduction, robust statistics, statistical computing and their broad applications in ecology, genetics, public health, and other areas of applied statistics.

Ray Liu, Ph.D., is Head of the Statistical Innovation and Consultation Center at Takeda Pharmaceuticals, Inc.  His research interests include design and analysis of omics studies, integrated analysis, and text mining.

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