Springer Series in Statistics

Sequential Experimentation in Clinical Trials

Design and Analysis

Authors: Bartroff, Jay, Lai, Tze Leung, Shih, Mei-Chiung

  • Interdisciplinary approach that Statistics researchers and advanced students will use, in addition to Statisticians working in medical fields
  • Includes recent work that provides a new class of adaptive designs which are both flexible and efficient - a new development for adaptive design literature
  • Uses a unique approach to: early phase I and II trials, both information and time-sequential phase III trials, the analysis following a clinical trial, the interactions between each of the stages
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  • ISBN 978-1-4614-6114-2
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  • Immediate eBook download after purchase
Hardcover $129.00
price for USA
  • ISBN 978-1-4614-6113-5
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $129.00
price for USA
  • ISBN 978-1-4899-9598-8
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Rent the ebook  
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About this book

Sequential Experimentation in Clinical Trials: Design and Analysis is developed from decades of work in research groups, statistical pedagogy, and workshop participation. Different parts of the book can be used for short courses on clinical trials, translational medical research, and sequential experimentation. The authors have successfully used the book to teach innovative clinical trial designs and statistical methods for Statistics Ph.D. students at Stanford University. There are additional online supplements for the book that include chapter-specific exercises and information.

Sequential Experimentation in Clinical Trials: Design and Analysis covers the much broader subject of sequential experimentation that includes group sequential and adaptive designs of Phase II and III clinical trials, which have attracted much attention in the past three decades. In particular, the broad scope of design and analysis problems in sequential experimentation clearly requires a wide range of statistical methods and models from nonlinear regression analysis, experimental design, dynamic programming, survival analysis, resampling, and likelihood and Bayesian inference. The background material in these building blocks is summarized in Chapter 2 and Chapter 3 and certain sections in Chapter 6 and Chapter 7. Besides group sequential tests and adaptive designs, the book also introduces sequential change-point detection methods in Chapter 5 in connection with pharmacovigilance and public health surveillance. Together with dynamic programming and approximate dynamic programming in Chapter 3, the book therefore covers all basic topics for a graduate course in sequential analysis designs.

About the authors

Jay Bartroff is Associate Professor of Mathematics at the University of Southern California where he is a member of the Laboratory of Applied Pharmacokinetics at the USC Keck School of Medicine.  He is a leading expert on group sequential and multistage adaptive statistical procedures and their applications to clinical trial designs, and he is a sought-after consultant in academia and industry.  Tze Leung Lai is Professor of Statistics, and by courtesy, of Health Research and Policy and of the Institute of Computational and Mathematical Engineering at Stanford University, where he is the Director of the Financial and Risk Modeling Institute and Co-director of the Biostatistics Core at the Stanford Cancer Institute and of the Center for Innovative Study Design at the School of Medicine. He made seminal contributions to sequential analysis, innovative clinical trial designs, adaptive methods, survival analysis, nonlinear and generalized mixed models, hybrid resampling methods, and received the Committee of Presidents of Statistical Societies (COPSS) Award in 1983.  Mei-Chiung Shih is Assistant Professor of Biostatistics and a member of the Stanford Cancer Institute and of the Center for Innovative Study Design at the School of Medicine at Stanford University.  She is also Associate Director for Scientific and Technical Operations at the Department of Veterans Affairs (VA) Cooperative Studies Program Coordinating Center at Palo Alto Health Care System.  She is a leading expert on group sequential and adaptive designs and inference of clinical trials, longitudinal and survival data analysis, and has been leading the design, conduct and analysis of several large trials at the VA.

Reviews

“This outstanding book written by three prominent scholars present in depth sequential designs and analyses for different clinical trials. … The book can also be used for short courses on clinical trials, translational medical research, and sequential experimentation by selecting the relevant parts of it.” (Subir Ghosh, Technometrics, Vol. 56 (4), November, 2014)

“It is definitely a ‘must read’ for anyone doing research into the theory or methodology of modern sequential statistical analysis.” (Bruce W. Turnbull, Mathematical Reviews, May, 2014)

Table of contents (8 chapters)

  • Introduction

    Bartroff, Jay (et al.)

    Pages 1-10

  • Nonlinear Regression, Experimental Design, and Phase I Clinical Trials

    Bartroff, Jay (et al.)

    Pages 11-35

  • Sequential Testing Theory and Stochastic Optimization Over Time

    Bartroff, Jay (et al.)

    Pages 37-75

  • Group Sequential Design of Phase II and III Trials

    Bartroff, Jay (et al.)

    Pages 77-100

  • Sequential Methods for Vaccine Safety Evaluation and Surveillance in Public Health

    Bartroff, Jay (et al.)

    Pages 101-122

Buy this book

eBook $99.00
price for USA (gross)
  • ISBN 978-1-4614-6114-2
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $129.00
price for USA
  • ISBN 978-1-4614-6113-5
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $129.00
price for USA
  • ISBN 978-1-4899-9598-8
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Rent the ebook  
  • Rental duration: 1 or 6 month
  • low-cost access
  • online reader with highlighting and note-making option
  • can be used across all devices
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Bibliographic Information

Bibliographic Information
Book Title
Sequential Experimentation in Clinical Trials
Book Subtitle
Design and Analysis
Authors
Series Title
Springer Series in Statistics
Series Volume
298
Copyright
2013
Publisher
Springer-Verlag New York
Copyright Holder
Springer Science+Business Media New York
eBook ISBN
978-1-4614-6114-2
DOI
10.1007/978-1-4614-6114-2
Hardcover ISBN
978-1-4614-6113-5
Softcover ISBN
978-1-4899-9598-8
Series ISSN
0172-7397
Edition Number
1
Number of Pages
XVI, 240
Topics