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Biopharmaceutical Applied Statistics Symposium

Volume 3 Pharmaceutical Applications

  • 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 and 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 (19 chapters)

  1. Front Matter

    Pages i-xv
    Download chapter PDF

  2. Targeted Learning of Optimal Individualized Treatment Rules Under Cost Constraints

    • Boriska Toth, Mark van der Laan
    Pages 1-22

  3. Overview of Omics Biomarker Discovery and Design Considerations for Biomarker-Informed Clinical Trials

    • Weidong Zhang, Bo Huang, Jing Wang, Sandeep Menon
    Pages 23-52

  4. Phase 3 Oncology Trials of Personalized Medicines with Adaptive Subpopulation Selection

    • Cong Chen, Wen Li, Xiaoyun (Nicole) Li, Robert A. Beckman
    Pages 53-64

  5. High-Dimensional Data in Genomics

    • Dhammika Amaratunga, Javier Cabrera
    Pages 65-73

  6. Synergy or Additivity—The Importance of Defining the Primary Endpoint and the Approach to Its Statistical Analysis—A Case Study

    • Bruce E. Rodda
    Pages 75-89

  7. Recycling of Significance Levels in Testing Multiple Hypotheses of Confirmatory Clinical Trials

    • Mohammad Huque, Sirisha Mushti, Mohamed Alosh
    Pages 91-118

  8. Statistical Testing of Single and Multiple Endpoint Hypotheses in Group Sequential Clinical Trials

    • Mohammad Huque, Sirisha Mushti, Mohamed Alosh
    Pages 119-149

  9. Expanded Statistical Decision Rules for Interpretations of Results of Rodent Carcinogenicity Studies of Pharmaceuticals

    • Karl K. Lin, Mohammad A. Rahman
    Pages 151-183

  10. A Prematurely Halted, Randomized, Controlled Clinical Trial of Alendronate Treatment in Patients with Gaucher Disease

    • Shumei S. Sun
    Pages 185-191

  11. Mediation Modeling in Randomized Trials with Non-normal Outcome Variables

    • Jing Cheng, Stuart A. Gansky
    Pages 193-217

  12. Statistical Considerations for Quantitative Imaging Measures in Clinical Trials

    • Ying Lu
    Pages 219-240

  13. Interesting Applications from Three Decades of Biostatistical Consulting

    • Karl E. Peace, Uche Eseoghene Okoro, Kao-Tai Tsai
    Pages 241-260

  14. Uncovering Fraud, Misconduct, and Other Data Quality Issues in Clinical Trials

    • Richard C. Zink
    Pages 261-276

  15. Design and Analysis of Biosimilar Studies

    • Shein-Chung Chow, Fuyu Song
    Pages 277-305

  16. Causal Estimands: A Common Language for Missing Data

    • Steven A. Gilbert, Ye Tan
    Pages 307-337

  17. Development of Prognostic Biomarker Signatures for Survival Using High-Dimensional Data

    • Richard Simon
    Pages 339-351

  18. Validation, Multivariate Modeling, and the Construction of Heat-Map Prediction Matrices for Survival in the Context of Missing Data

    • Shankar S. Srinivasan, Albert Elion-Mboussa, Li Hua Yue
    Pages 353-374

  19. Tepee Plots, Graphics for Structured Tabular Data, with Biopharmaceutical Examples

    • Shankar S. Srinivasan, Vatsala Karwe, Li Hua Yue
    Pages 375-395

  20. Some Methods for Longitudinal and Cross-Sectional Visualization with Further Applications in the Context of Heat Maps

    • Shankar S. Srinivasan, Li Hua Yue, Rick Soong, Mia He, Sibabrata Banerjee, Stanley Kotey
    Pages 397-420
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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 third of the 3-volume book series. The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine – Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development,  Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and OtherData Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.



Editors and Affiliations

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

    Karl E. Peace

  • School of Social Work and 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 3 Pharmaceutical Applications

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

  • Series Title: ICSA Book Series in Statistics

  • DOI: https://doi.org/10.1007/978-981-10-7820-0

  • Publisher: Springer Singapore

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

  • Copyright Information: Springer Nature Singapore Pte Ltd. 2018

  • Hardcover ISBN: 978-981-10-7819-4Published: 14 September 2018

  • Softcover ISBN: 978-981-13-4006-2Published: 29 December 2018

  • eBook ISBN: 978-981-10-7820-0Published: 03 September 2018

  • Series ISSN: 2199-0980

  • Series E-ISSN: 2199-0999

  • Edition Number: 1

  • Number of Pages: XV, 426

  • Number of Illustrations: 28 b/w illustrations, 46 illustrations in colour

  • Topics: Statistics for Life Sciences, Medicine, Health Sciences, Biostatistics

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