Design and Analysis of Clinical Trials

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Praise for the First Edition of Design and Analysis ofClinical Trials "An excellent book, providing a discussion of the clinical trialprocess from designing the study through analyzing the data, and toregulatory requirement. could easily be used as a classroomtext to understand the process in the new drug developmentarea." -Statistical Methods in Medicine A complete and balanced presentation now revised, updated, andexpanded As the field of research possibilities expands, the need for aworking understanding of how to carry out clinical trials onlyincreases. New developments in the theory and practice of clinicalresearch include a growing body of literature on the subject, newtechnologies and methodologies, and new guidelines from theInternational Conference on Harmonization (ICH). Design and Analysis of Clinical Trials, Second Editionprovides both a comprehensive, unified presentation of principlesand methodologies for various clinical trials, and a well-balancedsummary of current regulatory requirements. This unique resourcebridges the gap between clinical and statistical disciplines,covering both fields in a lucid and accessible manner. Thoroughlyupdated from its first edition, the Second Edition of Design andAnalysis of Clinical Trials features new topics such as: * Clinical trials and regulations, especially those of theICH * Clinical significance, reproducibility, andgeneralizability * Goals of clinical trials and target population * New study designs and trial types * Sample size determination on equivalence and noninferioritytrials, as well as comparing variabilities Also, three entirely new chapters cover: * Designs for cancer clinical trials * Preparation and implementation of a clinical protocol * Data management of a clinical trial Written with the practitioner in mind, the presentation assumesonly a minimal mathematical and statistical background for itsreader. Instead, the writing emphasizes real-life examples andillustrations from clinical case studies, as well as numerousreferences-280 of them new to the Second Edition-to the literature.Design and Analysis of Clinical Trials, Second Edition willbenefit academic, pharmaceutical, medical, and regulatoryscientists/researchers, statisticians, and graduate-level studentsin these areas by serving as a useful, thorough reference sourcefor clinical research.

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Shein-Chung Chow

Themen in »Design and Analysis of Clinical Trials«

Biowissenschaften Clinical Trials Gesundheits- u. Sozialwesen Health & Social Care Klinische Prüfung Klinische Studien Life Sciences Life Sciences Special Topics Public Health Services & Policy Spezialthemen Biowissenschaften Statistics Statistik Öffentlicher Gesundheitsdienst u. Gesundheitspolitik

Stimmen zu »Design and Analysis of Clinical Trials«

"It stands ready to satisfy the appetite of any pharmaceuticalscientist with a respectable statistical appetite." (Journal ofClinical Research, June 2008) "Biostatisticians, applied statisticians, and clinicalscientists will find this book very valuable, and it is suitablefor a graduate level clinical trial course." (Journal ofStatistical Computation and Simulation, September 2005) ".a comprehensive introduction.highlyrecommended." (Statistical Methods in MedicalResearch, Vol. 14, 2005) ".I will find this book a handy resource for futureconsulting with medical researchers." (Journal of the AmericanStatistical Association, June 2005) ".the authors have done a commendable job of blendinglarge amounts of statistical and regulatory information in a waythat is easy to comprehend and directly applicable."(Clinical Chemistry, April 2005) ".provides a comprehensive overview of the rather generalarea of clinical trials.an essential reference text."(Journal of Applied Statistics, Vol.32, No.3, April2005) "Numerous real-life examples and illustrations form clinicalcase studies are included." (Zentralblatt Math,Vol.1050, 2005) ".certainly comprehensive.should be a standard referencefor both clinical scientists and biostatisticians."(Technometrics, February 2005)
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