Clinical trials have taken a prominent role in the research and approval of drugs. This text offers a summary of statistical design, including cross-over designs, sample size estimation, sequential methods for interim analyses, survival analysis, and repeated measures. Series: Chapman & Hall/CRC Texts in Statistical Science. Num Pages: 464 pages, 4 black & white illustrations. BIC Classification: MMG; PB. Category: (G) General (US: Trade); (UU) Undergraduate. Dimension: 241 x 166 x 31. Weight in Grams: 844. . 2007. 1st Edition. Hardcover. . . . .

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Bibliographic Details

Title: Introduction to Statistical Methods for Clinical Trials
Publisher: Taylor & Francis Inc
Publication Date: 2007
Language: English
ISBN 10: 1584880279
ISBN 13: 9781584880271
Binding: Hardcover
Edition: 1st Edition
Condition: New

About this title

Synopsis

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.

About the Author

Thomas D. Cook, David L. DeMets

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