Biopharmaceutical Applied Statistics Symposium

1. Front Matter

   Pages i-xiii

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2. Collaborative Targeted Maximum Likelihood Estimation to Assess Causal Effects in Observational Studies

   • Susan Gruber, Mark van der Laan

   Pages 1-23

3. Generalized Tests in Clinical Trials

   • Stephan Ogenstad

   Pages 25-42

4. Discrete Time-to-Event and Rank-Based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity

   • Macaulay Okwuokenye

   Pages 43-56

5. Imputing Missing Data Using a Surrogate Biomarker: Analyzing the Incidence of Endometrial Hyperplasia

   • P. Lim, H. Jiang

   Pages 57-67

6. Advancing Interpretation of Patient-Reported Outcomes

   • Joseph C. Cappelleri, Andrew G. Bushmakin

   Pages 69-89

7. Network Meta-analysis

   • Joseph C. Cappelleri, William L. Baker

   Pages 91-105

8. Detecting Safety Signals Among Adverse Events in Clinical Trials

   • Richard C. Zink

   Pages 107-125

9. Meta-analysis for Rare Events in Clinical Trials

   • Ding-Geng Chen, Karl E. Peace

   Pages 127-150

10. Missing Data

    • Steven A. Gilbert, Jared C. Christensen

    Pages 151-173

11. Bayesian Subgroup Analysis with Hierarchical Models

    • Gene Pennello, Mark Rothmann

    Pages 175-192

12. A Question-Based Approach to the Analysis of Safety Data

    • Melvin S. Munsaka

    Pages 193-216

13. Analysis of Two-Stage Adaptive Trial Designs

    • Shein-Chung Chow, Min Lin

    Pages 217-241

14. Back Matter

    Pages 243-245

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This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials.  The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter.


The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications.  


This book is the second of the 3-volume book series. The topics covered include: Statistical Approaches to the Meta-analysis of Randomized Clinical Trials, Collaborative Targeted Maximum Likelihood Estimation to Assess Causal Effects in Observational Studies, Generalized Tests in Clinical Trials, Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free , Imputing Missing Data Using a Surrogate Biomarker: Analyzing the Incidence of Endometrial Hyperplasia, Selected Statistical Issues in Patient-reported Outcomes, Network Meta-analysis, Detecting Safety Signals Among Adverse Events in Clinical Trials, Applied Meta-analysis Using R, Treatment of Missing Data in Comparative Effectiveness Research, Causal Estimands: A Common Language for Missing Data, Bayesian Subgroup Analysis with Examples, Statistical Methods in Diagnostic Devices, A Question-Based Approach to the Analysis of Safety Data, Analysis of Two-stage AdaptiveSeamless Trial Design, and Multiplicity Problems in Clinical Trials – A Regulatory Perspective.

• Randomized Clinical Trials
• Generalized Tests
• Score-based Methods
• Evidence of Disease Activity-Free
• Endometrial Hyperplasia
• Surrogate Biomarker
• Network Meta-analysis
• Safety Signals
• Treatment of Missing Data
• Bayesian Subgroup Analysis
• Statistics

• Jiann-Ping Hsu College of Public Health, Georgia Southern University, Statesboro, USA

  Karl E. Peace

• School of Social Work & Gillings School of Global Public Health, University of North Carolina, Chapel Hill, USA

  Ding-Geng Chen

• Boston University, Cambridge, USA

  Sandeep Menon

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