Clinical trials have become essential research tools for evaluating
the benefits and risks of new interventions for the treatment and
prevention of diseases, from cardiovascular disease to cancer to
AIDS. Based on the authors' collective experiences in this field,
Introduction to Statistical Methods for Clinical Trials presents
various statistical topics relevant to the design, monitoring, and
analysis of a clinical trial.
After reviewing the history, ethics, protocol, and regulatory
issues of clinical trials, the book provides guidelines for
formulating primary and secondary questions and translating
clinical questions into statistical ones. It examines designs used
in clinical trials, presents methods for determining sample size,
and introduces constrained randomization procedures. The authors
also discuss how various types of data must be collected to answer
key questions in a trial. In addition, they explore common analysis
methods, describe statistical methods that determine what an
emerging trend represents, and present issues that arise in the
analysis of data. The book concludes with suggestions for reporting
trial results that are consistent with universal guidelines
recommended by medical journals.
Developed from a course taught at the University of Wisconsin
for the past 25 years, this textbook provides a solid understanding
of the statistical approaches used in the design, conduct, and
analysis of clinical trials.
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