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Statistical Design, Monitoring, and Analysis of Clinical Trials: Principles and Methods

Statistical Design, Monitoring, and Analysis of Clinical Trials: Principles and Methods

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  • More about Statistical Design, Monitoring, and Analysis of Clinical Trials: Principles and Methods


The book "Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition" focuses on the biostatistics component of clinical trials and is updated with five new chapters. It covers ethical and safety principles, core trial design concepts, sample size and power calculation, covariance and stratified analysis, sequential designs, monitoring safety, futility, and efficacy, and the development of sample size reestimation and adaptive group sequential procedures. It is suitable for students and practitioners in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

Format: Hardback
Length: 380 pages
Publication date: 26 October 2021
Publisher: Taylor & Francis Ltd


Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition, is a comprehensive guide that delves into the vital realm of biostatistics within clinical trials. This updated edition has been meticulously revised and expanded to include five new chapters, ensuring its relevance and timeliness. Authored by experienced educators, the text seamlessly blends fundamental scientific principles and statistical methodologies to provide a comprehensive understanding of biostatistics in clinical trials.

The book begins by exploring ethical and safety considerations, fundamental concepts of trial design, and the intricacies of sample size and power calculation. It then delves into advanced analysis techniques, such as covariance and stratified analysis, sequential designs, and methods for conducting Phase II to Phase III cancer trials. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design, trials with predictive biomarkers, the exploitation of multiple testing procedures, and the handling of incomplete data through proper multiple imputations.

This text encompasses the multifaceted aspects of clinical trials, encompassing academic research, commercial development, and public health implications. It serves as a valuable resource for students and practitioners in the fields of (bio)statistics, epidemiology, medicine, pharmacy, and public health, equipping them with a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials.

The book is organized into well-structured chapters, each accompanied by detailed explanations, examples, and exercises to reinforce learning. The balanced set of homework assignments and in-class exercises ensures that students grasp the key concepts and apply them effectively. Whether you are a novice in the field or seeking to enhance your expertise, Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition, is an indispensable guide that will deepen your understanding of biostatistics and its applications in clinical research.

Weight: 744g
Dimension: 160 x 242 x 32 (mm)
ISBN-13: 9780367772444
Edition number: 2 New edition

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