Weili (Hrsg.) He

Practical Considerations for Adaptive Trial Design and Implementation

Buch

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 designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting dr… Mehr

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Produktdetails

Weitere Autoren: Pinheiro, José (Hrsg.) / Kuznetsova, Olga M. (Hrsg.)

ISBN: 978-1-4939-1099-1
EAN: 9781493910991
Produktnummer: 16570067
Verlag: Springer-Verlag GmbH
Sprache: Englisch
Erscheinungsjahr: 2014
Seitenangabe: 416 S.
Masse: H24.1 cm x B16.0 cm x D2.9 cm 816 g
Abbildungen: Book; 80 schwarz-weiße und 40 farbige Abbildungen, 10 schwarz-weiße Tabellen, Bibliographie
Gewicht: 816

Über den Autor

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.