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Biopharmaceutical Applied Statistics Symposium

Volume 2 Biostatistical Analysis 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 (12 chapters)

  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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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 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.



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 2 Biostatistical Analysis of Clinical Trials

  • Editors: Karl E. Peace, Ding-Geng Chen, Sandeep Menon

  • Series Title: ICSA Book Series in Statistics

  • DOI: https://doi.org/10.1007/978-981-10-7826-2

  • Publisher: Springer Singapore

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

  • Copyright Information: Springer Nature Singapore Pte Ltd. 2018

  • Hardcover ISBN: 978-981-10-7825-5Published: 31 August 2018

  • Softcover ISBN: 978-981-13-4007-9Published: 10 January 2019

  • eBook ISBN: 978-981-10-7826-2Published: 21 August 2018

  • 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, Biostatistics

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