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Handbook of Adaptive Designs in Pharmaceutical and Clinical Development by Annpey Pong (Merck Research Laboratories, Rahway, New Jersey, USA) at Abbey's Bookshop,
Handbook of Adaptive Designs in Pharmaceutical and Clinical Development
— —
Annpey Pong (Merck Research Laboratories, Rahway, New Jersey, USA) Shein-Chung Chow

Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

Annpey Pong (Merck Research Laboratories, Rahway, New Jersey, USA),  Shein-Chung Chow

$94.99

Paperback

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English
CRC Press
30 June 2020
Clinical trials; Probability & statistics
In response to the US FDA’s Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the principles and latest statistical methodologies used when modifying trial procedures based on accrued data of ongoing clinical trials. The book also gives a well-balanced summary of current regulatory perspectives.

The first several chapters focus on the fundamental theory behind adaptive trial design, the application of the Bayesian approach to adaptive designs, and the impact of potential population shift due to protocol amendments. The book then presents a variety of statistical methods for group sequential design, classical design, dose-finding trials, Phase I/II and Phase II/III seamless adaptive designs, multiple stage seamless adaptive trial design, adaptive randomization trials, hypotheses-adaptive design, and treatment-adaptive design. It also covers predictive biomarker diagnostics for new drug development, clinical strategies for endpoint selection in translational research, the role of independent data monitoring committees in adaptive clinical trials, the enrichment process in targeted clinical trials for personalized medicine, applications of adaptive designs that use genomic or genetic information, adaptive trial simulation, and the efficiency of adaptive design. The final chapters discuss case studies as well as standard operating procedures for good adaptive practices.

With contributions from leading clinical researchers in the pharmaceutical industry, academia, and regulatory agencies, this handbook offers an up-to-date, complete treatment of the principles and methods of adaptive design and analysis. Along with reviewing recent developments, it examines issues commonly encountered when applying adaptive design methods in clinical trials.
Edited by:   ,
Imprint:   CRC Press
Country of Publication:   United Kingdom
Dimensions:   Height: 254mm,  Width: 178mm, 
Weight:   453g
ISBN:   9780367577117
ISBN 10:   0367577119
Pages:   496
Publication Date:  
Audience:   College/higher education ,  General/trade ,  Primary ,  ELT Advanced
Format:   Paperback
Publisher's Status:   Active

Annpey Pong is a manager in the Department of Biostatistics and Research Decision Sciences at Merck Research Laboratories. Dr. Pong is also the associate editor of the Journal of Biopharmaceutical Statistics. She earned her Ph.D. in statistics from Temple University. Shein-Chung Chow is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also a professor of clinical sciences at Duke–National University of Singapore Graduate Medical School and the editor of the Journal of Biopharmaceutical Statistics. He earned his Ph.D. in statistics from the University of Wisconsin–Madison.

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