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Statistical Design, Monitoring, and Analysis of Clinical Trials - Principles and Methods (Hardcover, 2nd edition)
Loot Price: R2,498
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Statistical Design, Monitoring, and Analysis of Clinical Trials - Principles and Methods (Hardcover, 2nd edition)
Series: Chapman & Hall/CRC Biostatistics Series
Expected to ship within 12 - 17 working days
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Statistical Design, Monitoring, and Analysis of Clinical Trials,
Second Edition concentrates on the biostatistics component of
clinical trials. This new edition is updated throughout and
includes five new chapters. Developed from the authors' courses
taught to public health and medical students, residents, and
fellows during the past 20 years, the text shows how biostatistics
in clinical trials is an integration of many fundamental scientific
principles and statistical methods. The book begins with ethical
and safety principles, core trial design concepts, the principles
and methods of sample size and power calculation, and analysis of
covariance and stratified analysis. It then focuses on sequential
designs and methods for two-stage Phase II cancer trials to Phase
III group sequential trials, covering monitoring safety, futility,
and efficacy. The authors also discuss the development of sample
size reestimation and adaptive group sequential procedures, phase
2/3 seamless design and trials with predictive biomarkers, exploit
multiple testing procedures, and explain the concept of estimand,
intercurrent events, and different missing data processes, and
describe how to analyze incomplete data by proper multiple
imputations. This text reflects the academic research, commercial
development, and public health aspects of clinical trials. It gives
students and practitioners a multidisciplinary understanding of the
concepts and techniques involved in designing, monitoring, and
analyzing various types of trials. The book's balanced set of
homework assignments and in-class exercises are appropriate for
students and researchers in (bio)statistics, epidemiology,
medicine, pharmacy, and public health.
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