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Introduction to statistical methods for clinical trials / edited by Thomas D. Cook, David L. DeMets.
- Format:
- Book
- Series:
- Texts in statistical science
- Chapman & Hall/CRC texts in statistical science series
- Language:
- English
- Subjects (All):
- Clinical trials--Statistical methods.
- Clinical trials.
- Clinical Trials as Topic--methods.
- Statistics as Topic--methods.
- Data Collection.
- Research Design.
- Medical Subjects:
- Clinical Trials as Topic--methods.
- Statistics as Topic--methods.
- Data Collection.
- Research Design.
- Physical Description:
- 1 online resource (xxiii, 439 pages) : illustrations.
- Place of Publication:
- Boca Raton : Chapman & Hall/CRC, [2008]
- System Details:
- text file
- Summary:
- 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.
- Providing a solid understanding of the statistical approaches used in clinical trials, this text shows that the results of randomized controlled trials are best understood through the application of sound statistical principles.
- Contents:
- Introduction to clinical trials
- Defining the question
- Study design
- Sample size
- Randomization
- Data collection and quality control
- Survival analysis
- Longitudinal data
- Quality of life
- Data monitoring and interim analysis
- Selected issues in the analysis
- Closeout and reporting.
- Notes:
- Includes bibliographical references (pages 405-426) and index.
- Electronic reproduction. Ipswich, MA Available via World Wide Web.
- Description based on print version record.
- ISBN:
- 9781420009965
- 1420009966
- Publisher Number:
- 99990025021
- Access Restriction:
- Restricted for use by site license.
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