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Autor: Weili He
ISBN-13: 9781493910991
Einband: Book
Seiten: 416
Gewicht: 759 g
Format: 244x167x22 mm
Sprache: Englisch

Practical Considerations for Adaptive Trial Design and Implementation

Statistics for Biology and Health
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Weili He is a Director and Senior Principle Scientist of Clinical Biostatistics at Merck & Co., Inc. She has a Ph.D. degree in biostatistics. She has extensive experience in drug development, and has worked in many therapeutic areas over the years. Dr. He has been active both at Merck and in industry for initiatives relating to adaptive trials, with particular focus on adaptive trial design and implementation. She is a core member of the DIA Adaptive Design Scientific Working Group (ADSWG) and co-chair of the DIA ADSWG KOL Lecture series. Her research and collaboration with colleagues in various disciplines has led to over 30 publications in statistical and medical journals.
José Pinheiro has a Ph.D. in Statistics from the University of Wisconsin - Madison, having worked at Bell Labs and Novartis Pharmaceuticals, before his current position as Head of Statistical Modeling in the Model-Based Drug Development department at Janssen Research & Development. He has been involved in methodological development in various areas of statistics and drug development, including dose-finding, adaptive designs and mixed-effects models. He is a Fellow of the American Statistical Association, former co-chair of the PhRMA working group on Adaptive Dose-Ranging Studies, former core member of the PhRMA working group on Novel Adaptive Designs and co-developer of the nlme library/package in S-PLUS and R for linear and non-linear mixed-effects models.

Olga Kuznetsova is a Senior Principal Scientist in the Late Development Statistics department of Merck & Co., Inc. She has a PhD in probability theory and mathematical statistics and more than 15 years of experience in clinical trials. In the last decade, her research interests centered around randomization techniques in clinical trials, in particular, addressing the randomization needs of adaptive design trials. Her collaboration with colleagues on randomization issues resulted in more than 20 presentations and publications.
Covers in detail design and implementation of the full scope of adaptive clinical trial designs
Introduction.- Practical considerations of adaptive trial design.- Design consideration.- Reflection on The FDA Draft Guidance On Adaptive Designs from industry perspective.- Design consideration.- Regulatory perspective on the FDA draft guidance.- Design consideration.- Good clinical practices for Adaptive Clinical Trials in Pharmaceutical Product Development.- Design consideration.- Considerations and optimizations of adaptive trial design in clinical development program.
This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive arena, it will serve as a valuable reference for researchers working in industry, governmental bodies and academia. This includes anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, clinical operation specialists, drug supplies managers, infrastructure providers. In spite of the increased efficiency of adaptive trials, which get drugs to patients faster through cost and time savings, the adoption of adaptive designs in clinical development is still relatively low. One of the chief reasons is the complexity of adaptive design trials as compared to traditional trials. Little has been published to address the practical aspects of these trials and recommend best practices and solutions. This volume does just that by addressing study design and conduct integrity, regulatory acceptance, advanced infrastructure used for complex randomization and clinical supply scenarios, change management for process and behavior modifications, resource requirements and the inclusion of outside entities in decision-making. The book consists of three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory scenarios the authors faced in trial implementation.
Bringing together the expertise of leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.
Editiert von: Weili He, José Pinheiro, Olga M. Kuznetsova
Weili He is a Director and Senior Principle Scientist of Clinical Biostatistics at Merck & Co., Inc. She has a Ph.D. degree in biostatistics. She has extensive experience in drug development, and has worked in many therapeutic areas over the years. Dr. He has been active both at Merck and in industry for initiatives relating to adaptive trials, with particular focus on adaptive trial design and implementation. She is a core member of the DIA Adaptive Design Scientific Working Group (ADSWG) and co-chair of the DIA ADSWG KOL Lecture series. Her research and collaboration with colleagues in various disciplines has led to over 30 publications in statistical and medical journals.
José Pinheiro has a Ph.D. in Statistics from the University of Wisconsin - Madison, having worked at Bell Labs and Novartis Pharmaceuticals, before his current position as Head of Statistical Modeling in the Model-Based Drug Development department at Janssen Research & Development. He has been involved in methodological development in various areas of statistics and drug development, including dose-finding, adaptive designs and mixed-effects models. He is a Fellow of the American Statistical Association, former co-chair of the PhRMA working group on Adaptive Dose-Ranging Studies, former core member of the PhRMA working group on Novel Adaptive Designs and co-developer of the nlme library/package in S-PLUS and R for linear and non-linear mixed-effects models.

Olga Kuznetsova is a Senior Principal Scientist in the Late Development Statistics department of Merck & Co., Inc. She has a PhD in probability theory and mathematical statistics and more than 15 years of experience in clinical trials. In the last decade, her research interests centered around randomization techniques in clinical trials, in particular, addressing the randomization needs of adaptive design trials. Her collaboration with colleagues on randomization issues resulted in more than 20 presentations and publications.

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Autor: Weili He
ISBN-13 :: 9781493910991
ISBN: 149391099X
Erscheinungsjahr: 01.11.2014
Verlag: Springer-Verlag GmbH
Gewicht: 759g
Seiten: 416
Sprache: Englisch
Sonstiges: Buch, 244x167x22 mm, 80 schwarz-weiße und 40 farbige Abbildungen, 10 schwarz-weiße Tabellen, Bibliographie