Editors:
- Offers a curated collection of perspectives from experts in the field who are involved in the design, analysis, and application of pharmaceutical statistics related to subgroup methodology
- Grounds methods and real-data applications in state-of-the-field techniques and direction
- Highlights recent advances that have major clinical relevance, designed to have particular appeal to practitioners in the field
- Discusses the appropriate use of subgroup design and analysis, cutting-edge methods on identification of subgroups, and potential fallacies of subgroup analysis
Part of the book series: Emerging Topics in Statistics and Biostatistics (ETSB)
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Table of contents (18 chapters)
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Front Matter
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Subgroups in Clinical Trial Design and Analysis
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Front Matter
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Subgroup Identification and Personalized Medicine
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Front Matter
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General Issues About Subgroup Analysis, Including Regulatory Considerations
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Front Matter
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About this book
This book provides an overview of the theories and applications on subgroups in the biopharmaceutical industry. Drawing from a range of expert perspectives in academia and industry, this collection offers an overarching dialogue about recent advances in biopharmaceutical applications, novel statistical and methodological developments, and potential future directions.
The volume covers topics in subgroups in clinical trial design; subgroup identification and personalized medicine; and general issues in subgroup analyses, including regulatory ones. Included chapters present current methods, theories, and case applications in the diverse field of subgroup application and analysis. Offering timely perspectives from a range of authoritative sources, the volume is designed to have wide appeal to professionals in the pharmaceutical industry and to graduate students and researchers in academe and government.
Editors and Affiliations
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Biostatistics & Data Sciences, Boehringer Ingelheim Corporation, Ridgefield, USA
Naitee Ting
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Pfizer Inc, Groton, USA
Joseph C. Cappelleri
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UCB Biosciences Inc., Raleigh, USA
Shuyen Ho
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School of Social Work, University of North Carolina, Chapel Hill, USA
(Din) Ding-Geng Chen
About the editors
Joseph C. Cappelleri is an executive director of biostatistics in the Statistical Research and Data Science Center at Pfizer, Inc. As an adjunct professor, he has served on the faculties at Brown University (biostatistics), Tufts Medical Center (medicine), and the University of Connecticut (statistics). He has co-authored approximately 1000 external presentations and 500 publications on clinical and methodological topics, including on regression-discontinuity designs, meta-analysis, and health measurement scales. Dr. Cappelleri is the lead author of the book Patient-Reported Outcomes: Measurement, Implementation and Interpretation (2013, with Zou, Bushmakin, Alvir, Alemayehu, and Symonds), and has co-authored or co-edited two other books (one on Phase II clinical trials, the other on health economics and outcomes research). He is a Fellow of the American Statistical Association.
Shuyen Ho is a lead research biostatistician at UCB BioSciences in Raleigh, North Carolina. Prior to UCB, he was a biostatistics director at PAREXEL and GlaxoSmithKline (GSK), and a group leader and research statistician at Merck. He has been involved in developing allergy, asthma, COPD (chronic obstructive pulmonary disease) and some other rare disease medications. Dr. Ho has also actively served the International Chinese Statistical Association (ICSA) as a board director, symposium and program committee chair, and executive director.
Ding-Geng (Din) Chen is the Wallace H. Kuralt Distinguished Professor and Director of the Consortium for Statistical Development and Consultation (CSDC) in the School of Social Work, and is jointly appointed as a clinical professorin the Department of Biostatistics at the UNC Gillings School of Global Health. He is an elected fellow of American Statistical Association. As a professor in biostatistics, he is interested in developing biostatistical methodologies in clinical trials, meta-analysis, Bayesian statistics and their applications to public health. As a professor in social work, he is interested in developing Bayesian social and health intervention research, cusp catastrophe modelling, statistical causal inferences, propensity score and structural-equation models (SEM). He is PI/Co-PI for several NIH R01 research projects in biostatistical methodology development and public health applications.
Bibliographic Information
Book Title: Design and Analysis of Subgroups with Biopharmaceutical Applications
Editors: Naitee Ting, Joseph C. Cappelleri, Shuyen Ho, (Din) Ding-Geng Chen
Series Title: Emerging Topics in Statistics and Biostatistics
DOI: https://doi.org/10.1007/978-3-030-40105-4
Publisher: Springer Cham
eBook Packages: Mathematics and Statistics, Mathematics and Statistics (R0)
Copyright Information: Springer Nature Switzerland AG 2020
Hardcover ISBN: 978-3-030-40104-7Published: 02 May 2020
Softcover ISBN: 978-3-030-40107-8Published: 02 May 2021
eBook ISBN: 978-3-030-40105-4Published: 01 May 2020
Series ISSN: 2524-7735
Series E-ISSN: 2524-7743
Edition Number: 1
Number of Pages: XVIII, 400
Number of Illustrations: 18 b/w illustrations, 43 illustrations in colour
Topics: Statistics for Life Sciences, Medicine, Health Sciences, Biostatistics, Pharmaceutical Sciences/Technology