© 2018

Biopharmaceutical Applied Statistics Symposium

Volume 2 Biostatistical Analysis of Clinical Trials

  • Karl E. Peace
  • Ding-Geng Chen
  • Sandeep Menon

Part of the ICSA Book Series in Statistics book series (ICSABSS)

Table of contents

  1. Front Matter
    Pages i-xiii
  2. Stephan Ogenstad
    Pages 25-42
  3. Joseph C. Cappelleri, Andrew G. Bushmakin
    Pages 69-89
  4. Joseph C. Cappelleri, William L. Baker
    Pages 91-105
  5. Ding-Geng Chen, Karl E. Peace
    Pages 127-150
  6. Steven A. Gilbert, Jared C. Christensen
    Pages 151-173
  7. Gene Pennello, Mark Rothmann
    Pages 175-192
  8. Shein-Chung Chow, Min Lin
    Pages 217-241
  9. Back Matter
    Pages 243-245

About this book


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 Adaptive Seamless 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

Editors and affiliations

  • Karl E. Peace
    • 1
  • Ding-Geng Chen
    • 2
  • Sandeep Menon
    • 3
  1. 1.Jiann-Ping Hsu College of Public HealthGeorgia Southern UniversityStatesboroUSA
  2. 2.School of Social Work & Gillings School of Global Public HealthUniversity of North CarolinaChapel HillUSA
  3. 3.Boston UniversityCambridgeUSA

Bibliographic information

  • Book Title Biopharmaceutical Applied Statistics Symposium
  • Book Subtitle Volume 2 Biostatistical Analysis of Clinical Trials
  • Editors Karl E. Peace
    Ding-Geng Chen
    Sandeep Menon
  • Series Title ICSA Book Series in Statistics
  • Series Abbreviated Title ICSA Book Series in Statistics
  • DOI
  • Copyright Information Springer Nature Singapore Pte Ltd. 2018
  • Publisher Name Springer, Singapore
  • eBook Packages Mathematics and Statistics Mathematics and Statistics (R0)
  • Hardcover ISBN 978-981-10-7825-5
  • Softcover ISBN 978-981-13-4007-9
  • eBook ISBN 978-981-10-7826-2
  • Series ISSN 2199-0980
  • Series E-ISSN 2199-0999
  • Edition Number 1
  • Number of Pages XIII, 245
  • Number of Illustrations 16 b/w illustrations, 18 illustrations in colour
  • Topics Statistics for Life Sciences, Medicine, Health Sciences
  • Buy this book on publisher's site
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