© 2018

Biopharmaceutical Applied Statistics Symposium

Volume 1 Design of Clinical Trials

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


  • Discusses updated design and analysis methods for biopharmaceutical clinical trials

  • Includes chapters written by internationally respected authors from academia, government and industry who possess substantial hands-on experience designing and analyzing biopharmaceutical clinical trials

  • Provides illustrative examples of the design and analysis of biopharmaceutical clinical trials

  • Provides computer programs to facilitate the understanding and applications


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

Table of contents

  1. Front Matter
    Pages i-xiv
  2. Annpey Pong, Shein-Chung Chow
    Pages 75-99
  3. Cristiana Mayer, J. Kyle Wathen
    Pages 101-114
  4. Gheorghe Doros, Pilar Lim, Yuyin Liu
    Pages 171-203
  5. Ying Yuan, Heng Zhou, Yanhong Zhou
    Pages 205-233
  6. Chi-Tian Chen, Hsiao-Hui Tsou, Jung-Tzu Liu, Chin-Fu Hsiao, Fei Chen, Gang Li et al.
    Pages 269-286
  7. Yoko Tanaka, Bruce Binkowitz, Bill Wang
    Pages 287-295
  8. Lori D. McLeod, Sheri E. Fehnel, Joseph C. Cappelleri
    Pages 317-346
  9. Back Matter
    Pages 405-409

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 first of the 3-vol
ume book series. The topics covered include: A Statistical Approach to Clinical Trial Simulations, Comparison of Statistical Analysis Methods Using Modeling and Simulation for Optimal Protocol Design, Adaptive Trial Design in Clinical Research, Best Practices and Recommendations for Trial Simulations in the Context of Designing Adaptive Clinical Trials, Designing and Analyzing Recurrent Event Data Trials, Bayesian Methodologies for Response-Adaptive Allocation, Addressing High Placebo Response in Neuroscience Clinical Trials, Phase I Cancer Clinical Trial Design: Single and Combination Agents, Sample Size and Power for the Mixed Linear Model, Crossover Designs in Clinical Trials, Data Monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures, Design and Data Analysis for Multiregional Clinical Trials – Theory and Practice, Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines, Development and Validation of Patient-reported Outcomes, Interim Analysis of Survival Trials: Group Sequential Analyses, and Conditional Power – A Non-proportional Hazards Perspective.


Clinical Trial Simulations Optimal Protocol Design Statistical Analysis Recurrent Event Data Trials Response-Adaptive Allocation Neuroscience Clinical Trials Phase I Cancer Clinical Trial Design Data Monitoring Multiregional Clinical Trials Group Sequential Analyses

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 1 Design 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 978-981-10-7828-6
  • Softcover ISBN 978-981-13-4008-6
  • eBook ISBN 978-981-10-7829-3
  • Series ISSN 2199-0980
  • Series E-ISSN 2199-0999
  • Edition Number 1
  • Number of Pages XIV, 409
  • Number of Illustrations 26 b/w illustrations, 28 illustrations in colour
  • Topics Statistics for Life Sciences, Medicine, Health Sciences
  • Buy this book on publisher's site
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