Adaptive Design Methods in Clinical Trials - Chow, Shein-Chung

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Auteur(s) : Chow, Shein-Chung - Chang, Mark

Editeur : Chapman And Hall/Crc

Langue : Anglais

Parution : 01/12/2011

Format : Moyen, de 350g à 1kg

Nombre de pages : 376.0

Expédition : 680

Dimensions : 23.1 x 16.3 x 2.5

ISBN : 9781439839874

Résumé :

This acclaimed book covers the principles and methodologies in adaptive design and analysis that pertain to adaptations made to trial or statistical procedures based on accrued data of ongoing clinical trials. It presents a well-balanced summary of current regulatory perspectives, recently developed statistical methods, and statistical tests for seamless phase II/III adaptive designs. This edition features two new chapters as well as a complete rewrite of the chapter on computer simulation. It also includes computer simulations and various case studies to ensure a practical understanding of the methodologies.

Biographie:

Shein-Chung Chow is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also an adjunct professor of clinical sciences at Duke-National University of Singapore Graduate Medical School and the editor-in-chief of the Journal of Biopharmaceutical Statistics. He has authored or co-authored numerous papers and books, including the Handbook of Adaptive Designs in Pharmaceutical and Clinical Development and Controversial Statistical Issues in Clinical Trials.

Mark Chang is the executive director of biostatistics and data management at AMAG Pharmaceuticals and an adjunct professor at Boston University. A fellow of the American Statistical Association, Dr. Chang is a co-founder of the International Society for Biopharmaceutical Statistics and serves on the editorial boards of two statistical journals. He has authored many publications, including Adaptive Design Theory and Implementation Using SAS and R and Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies.

Sommaire:

Introduction. Protocol Amendment. Adaptive Randomization. Adaptive Hypotheses. Adaptive Dose-Escalation Trials. Adaptive Group Sequential Design. Statistical Tests for Seamless Adaptive Designs. Adaptive Sample Size Adjustment. Two-Stage Adaptive Design. Adaptive Treatment Switching. Bayesian Approach. Biomarker Adaptive Trials. Target Clinical Trials. Sample Size and Power Estimation. Clinical Trial Simulation. Regulatory Perspectives - A Review of FDA Draft Guidance. Case Studies. Bibliography. Subject Index.

This second edition remains a useful reference source for anyone interested in advancing innovative trial designs and wishing to incorporate adaptations, modifications, and changes to the drug development process. Five new chapters have been added and are all worth reading; bringing the technical material covered up-to-date. For anyone working in, and studying, clinical research the book is worth purchasing and will make a valuable addition to any library. ... this revision continues to provide a balanced summary of statistical methods, together with the authors' perspective on current regulatory practice. -International Statistical Review, 80, 2012 Praise for the First Edition The authors are to be commended for the endeavour to provide a monograph about this rapidly evolving area in- to our knowledge- the first book specifically devoted to adaptive design methods ... we think it provides a valuable contribution to the area of adaptive design. -Frank Miller and Stig Johan Wiklund, AstraZeneca, Statistical Medicine, 2008, Vol. 27 In summary, this is an extremely useful book for clinical trials statisticians wishing to stay abreast with the innovative approaches that are being developed amid some controversies regarding their benefits. -Yuko Palesch, Medical University of South Carolina, Journal of the American Statistical Association, March 2008, Vol. 103, No. 481 ...This book is one of the first of its kind to be released solely dealing with adaptive designs in clinical trials. ... a useful reference for those who have a mathematical background and wish to understand some of the adaptive design methodologies. ...With the ever-increasing need for adaptive trials, we could see this book having a large influence ... -Pharmaceutical Statistics, 2008 ...a useful reference source for anyone interested in advancing innovative trial designs and wishing to incorporate adaptations, modifications, and changes to the drug, device, and biological developmental processes. -C.M. O'Brien, International Statistical Review, Vol. 75, No. 2, 2007 ...uses a broad definition of adaptive design methods... .This breadth of coverage is to be commended and makes the book a useful reference and overview for anyone who is starting to explore this area ... the book is worth reading. -Angela Wade, University College London, UK The book covers a vast area. To my knowledge this book is the first attempt to provide a concise description of various methodologies in a highly dynamic area. The authors deserve to be praised for bringing this huge range of approaches, including very recent trends, together in one book ... . -Tim Friede, University of Warwick, Biometrics, March 2008