Applied Statistics in Biomedicine and Clinical Trials Design

1. Front Matter

   Pages i-xxiv

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2. Bayesian Methods In Biomedical Research

   1. Front Matter

      Pages 1-1

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   2. An Application of Bayesian Approach for Testing Non-inferiority Case Studies in Vaccine Trials

      • G. Frank Liu, Shu-Chih Su, Ivan S. F. Chan

      Pages 3-15

   3. Bayesian Design of Noninferiority Clinical Trials with Co-primary Endpoints and Multiple Dose Comparison

      • Wenqing Li, Ming-Hui Chen, Huaming Tan, Dipak K. Dey

      Pages 17-33

   4. Bayesian Functional Mixed Models for Survival Responses with Application to Prostate Cancer

      • Veerabhadran Baladandayuthapan, Xiaohui Wang, Bani K. Mallick, Kim-Anh Do

      Pages 35-59

   5. Bayesian Predictive Approach to Early Termination for Enriched Enrollment Randomized Withdrawal Trials

      • Yang (Joy) Ge

      Pages 61-71

3. Diagnostic Medicine And Classification

   1. Front Matter

      Pages 73-73

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   2. Estimation of ROC Curve with Multiple Types of Missing Gold Standard

      • Danping Liu, Xiao-Hua Zhou

      Pages 75-87

   3. Group Sequential Methods for Comparing Correlated Receiver Operating Characteristic Curves

      • Xuan Ye, Liansheng Larry Tang

      Pages 89-108

   4. Nonparametric Covariate Adjustment for the Youden Index

      • Haochuan Zhou, Gengsheng Qin

      Pages 109-132

   5. Comparative Effectiveness Research Using Meta-Analysis to Evaluate and Summarize Diagnostic Accuracy

      • Kelly H. Zou, Ching-Ray Yu, Steven A. Willke, Ye Tan, Martin O. Carlsson

      Pages 133-145

4. Diagnostic Medicine And Classification

   1. Front Matter

      Pages 147-147

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   2. Some Characteristics of the Varying-Stage Adaptive Phase II/III Clinical Trial Design

      • Gaohong Dong

      Pages 149-161

   3. Collective Evidence in Drug Evaluation

      • Qian H. Li

      Pages 163-184

   4. Applications of Probability of Study Success in Clinical Drug Development

      • Ming-Dauh Wang

      Pages 185-196

   5. Treatment Effect Estimation in Adaptive Clinical Trials: A Review

      • Ying Yang, Huyuan Yang

      Pages 197-202

   6. Inferiority Index, Margin Functions, and Hybrid Designs for Noninferiority Trials with Binary Outcomes

      • George Y. H. Chi

      Pages 203-234

   7. Group-Sequential Designs When Considering Two Binary Outcomes as Co-Primary Endpoints

      • Koko Asakura, Toshimitsu Hamasaki, Scott R. Evans, Tomoyuki Sugimoto, Takashi Sozu

      Pages 235-262

   8. Issues in the Use of Existing Data: As Controls in Pre-Market Comparative Clinical Studies

      • Lilly Q. Yue

      Pages 263-271

   9. A Two-Tier Procedure for Designing and Analyzing Medical Device Trials Conducted in US and OUS Regions for Regulatory Decision Making

      • Nelson Lu, Yunling Xu, Gerry Gray

      Pages 273-284

This volume is a unique combination of papers that cover critical topics in biostatistics from academic, government, and industry perspectives. The 6 sections cover Bayesian methods in biomedical research; Diagnostic medicine and classification; Innovative Clinical Trials Design; Modelling and Data Analysis; Personalized Medicine; and Statistical Genomics. The real world applications are in clinical trials, diagnostic medicine and genetics. The peer-reviewed contributions were solicited and selected from some 400 presentations at the annual meeting of the International Chinese Statistical Association (ICSA), held with the International Society for Biopharmaceutical Statistics (ISBS). The conference was held in Bethesda in June 2013, and the material has been subsequently edited and expanded to cover the most recent developments.

• Bayesian statistics in clinical trials
• Clinical trials design
• Diagnostic medicine
• High-dimensional data mining and analysis
• Innovative clinical designs
• Modeling and data analysis
• Personalized medicine
• Statistical genetics
• Statistical genomics
• Statistics biomedical research
• Statistics biomedicine

• National Institutes of Health, Rockville, USA

  Zhen Chen, Aiyi Liu

• Lilly Corporation Center, Indianapolis, USA

  Yongming Qu

• George Mason University, Fairfax, USA

  Larry Tang

• Boehringer-Ingelheim, Ridgefield, USA

  Naitee Ting

• Food and Drug Administration, Silver Spring, USA

  Yi Tsong

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