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Biopharmaceutical Applied Statistics Symposium

Volume 1 Design of Clinical Trials

  • Book
  • © 2018

Overview

Editors:
  1. Karl E. Peace

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

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  2. Ding-Geng Chen

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

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    You can also search for this editor in PubMed   Google Scholar

  3. Sandeep Menon

    1. Boston University, Cambridge, USA

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  • 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 book series: ICSA Book Series in Statistics (ICSABSS)

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Table of contents (15 chapters)

  1. Front Matter

    Pages i-xiv
    Download chapter PDF

  2. A Statistical Approach to Clinical Trial Simulations

    • Stephan Ogenstad
    Pages 1-18

  3. Choosing the Function of Baseline Run-in Data for Use as a Covariate in the Analysis of Treatment Data from Phase III Clinical Trials in Hypertension

    • Yi Hao, Karl E. Peace
    Pages 19-74

  4. Adaptive Trial Design in Clinical Research

    • Annpey Pong, Shein-Chung Chow
    Pages 75-99

  5. Best Practices in Clinical Trial Simulations for Adaptive Study Designs

    • Cristiana Mayer, J. Kyle Wathen
    Pages 101-114

  6. Designing and Analyzing Recurrent Event Data Trials

    • Stephan Ogenstad
    Pages 115-147

  7. Response-Adaptive Allocation for Binary Outcomes: Bayesian Methods from the BASS Conference

    • Roy T. Sabo
    Pages 149-169

  8. Addressing High Placebo Response in Neuroscience Clinical Trials

    • Gheorghe Doros, Pilar Lim, Yuyin Liu
    Pages 171-203

  9. Phase I Cancer Clinical Trial Design: Single and Combination Agents

    • Ying Yuan, Heng Zhou, Yanhong Zhou
    Pages 205-233

  10. Data Monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures

    • David M. Reboussin, Dave L. DeMets
    Pages 235-267

  11. Design and Data Analysis of Multiregional Clinical Trials (MRCTs)—Theory and Practice

    • Chi-Tian Chen, Hsiao-Hui Tsou, Jung-Tzu Liu, Chin-Fu Hsiao, Fei Chen, Gang Li et al.
    Pages 269-286

  12. Multi-Regional Clinical Trials, ICH-E17, and Subpopulations

    • Yoko Tanaka, Bruce Binkowitz, Bill Wang
    Pages 287-295

  13. Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines

    • Inna Perevozskaya
    Pages 297-315

  14. Patient-Reported Outcome Measures: Development and Psychometric Evaluation

    • Lori D. McLeod, Sheri E. Fehnel, Joseph C. Cappelleri
    Pages 317-346

  15. Interim Analyses: Design and Analysis Considerations for Survival Trials When Hazards May Be Nonproportional

    • Edward Lakatos
    Pages 347-376

  16. On Design and Analysis of Dose-Response Trials for Early Clinical Development

    • Qing Liu
    Pages 377-403

  17. Back Matter

    Pages 405-409
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Keywords

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
umebook 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.

Editors and Affiliations

  • 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

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

  • DOI: https://doi.org/10.1007/978-981-10-7829-3

  • Publisher: Springer Singapore

  • eBook Packages: Mathematics and Statistics, Mathematics and Statistics (R0)

  • Copyright Information: Springer Nature Singapore Pte Ltd. 2018

  • Hardcover ISBN: 978-981-10-7828-6Published: 30 August 2018

  • Softcover ISBN: 978-981-13-4008-6Published: 16 December 2018

  • eBook ISBN: 978-981-10-7829-3Published: 20 August 2018

  • 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, Biostatistics

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