Editors:
- 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)
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Front Matter
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Back Matter
About this book
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. Â
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
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Jiann-Ping Hsu College of Public Health, Georgia Southern University, Statesboro, USA
Karl E. Peace
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School of Social Work & Gillings School of Global Public Health, University of North Carolina, Chapel Hill, USA
Ding-Geng Chen
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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