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Textbook of clinical trials in oncology : a statistical perspective

Author: Susan Halabi; Stefan Michiels
Publisher: Boca Raton, Florida : CRC Press, [2019]
Edition/Format:   eBook : Document : EnglishView all editions and formats
Summary:
There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Textbook of clinical trials in oncology.
Boca Raton, Florida : CRC Press, [2019]
(DLC) 2019006740
(OCoLC)1088601647
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Susan Halabi; Stefan Michiels
ISBN: 9781315112084 1315112086 9781351620970 1351620975 9781351620963 1351620967 9781351620956 1351620959
OCLC Number: 1098280014
Description: 1 online resource
Contents: Section I IntroductionIntroduction to Clinical Trials - Susan Halabi, Stefan MichielsSection II General IssuesSelection of Endpoints - Katherine S Panageas and Andrea KnezevicSection III Early DevelopmentInnovative Phase I Trials - Cody Chiuzan and Nathaniel O'ConnellSection IV Middle DevelopmentCurrent Issues in Phase II Cancer Clinical Trials - Sin-Ho JungDesign and Analysis of Immunotherapy Clinical Trials - Megan OthusAdaptive Designs - William T. BarrySection V Late Phase Clinical TrialsSample Size Calculations for Phase III Trials in Oncology - Koji Oba, Aye KuchibaNon-inferiority Trial - Keyue Ding, Chris O'Callaghan Design of Multi-arm, Multi-stage Trials in Oncology - James WasonMultiple Comparisons, Multiple Primary Endpoints and Subpopulation Analysis - Ekkehard Glimm, Dong Xi, Paul GalloCluster Randomized Trials - Catherine M. CrespiStatistical Monitoring of Safety and Efficacy - Jay Herson, Chen HuSection VI Personalized MedicineBiomarker-Based Phase II and III Clinical Trials in Oncology - Shigeyuki Matsui, Masataka Igeta, Kiichiro ToyoizumiGenomic Biomarker Clinical Trial Designs - Richard SimonTrial designs for rare diseases and small samples in oncology - Robert A. Beckman, Cong Chen, Martin Posch and Sarah ZoharStatistical Methods for Biomarker and Subgroup Evaluation in Oncology Trials - Ilya Lipkovich, Alex Dmitrienko, Bohdana RatitchDeveloping and Validating Prognostic Models of Clinical Outcomes - Susan Halabi, Lira Pi, and Chen-Yen LinHigh-Dimensional Penalized Regression Models in Time-to-Event Clinical Trials - Federico Rotolo, Nils Ternes, Stefan MichielsSequential Multiple Assignment Randomized Trials - Kelly Speth, Kelley M. KidwellSection VII Advanced TopicsAssessing the value of surrogate endpoints - Xavier Paoletti, Federico Rotolo, Stefan MichielsCompeting Risks - Aurelien Latouche, Gang Li, Qing YangCure models in cancer clinical trials - Catherine Legrand, Aurelie BertrandInterval Censoring - Yuan WuMethods for analysis of trials with changes from randomised treatment - Nicholas R. Latimer and Ian R. WhiteThe analysis of adverse events in randomized clinical trials - Jan Beyersmann, Claudia SchmoorAnalysis of quality of life outcomes in oncology trials - Stephen WaltersMissing Data - Stephanie Pugh, James J. Dignam, Juned Siddique
Responsibility: edited by Susan Halabi, Stefan Michiels.

Abstract:

There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book's website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others

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"This highly anticipated book focuses on clinical trials in oncology, ranging from early, middle, and late phase trials to advanced topics such as precision medicine and immunotherapy. This textbook Read more...

 
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