Fundamental Concepts for Clinical Trial Statisticians
Purchasing Options
Features
- Provides guidance on how statisticians can apply their knowledge to address real world clinical trial issues
- Includes balanced coverage drawn from academia and industry
- Discusses the evolving role of clinical trial statisticians and their contributions
- Supplies a resource for statisticians currently working in the field and for teaching clinical trials/biostatistics courses
Summary
With complete coverage of issues in all phases of clinical trials, including design, data monitoring, analyses, interpretation, and reporting, this book provides an overview of fundamental concepts important to statisticians working with clinical trials. It examines issues related to product development and regulation, and then discusses the attributes that statisticians can acquire to maximize their contribution to the research. The co-authors draw on their experience in industry and academia to provide balanced, practical guidance on how statisticians can apply their knowledge to address real world clinical trial issues.
Table of Contents
Clinical Trials and Statisticians. Clinical Trials. Clinical Trial Statisticians. Product Development Process. The Development Process of Drugs and Biologics. The Food and Drug Administration and Other Review Organizations. Design. General Consideration in Clinical Trial Designs. Specific Clinical Trial Designs. Data Monitoring. Data . Monitoring. Analyses. Analysis of Clinical Trials. Commonly Used Statistical Methods. Analysis of Safety, Quality of Life, and Benefit: Risk. Other Topics. Special Issues for Devices and Biologics. Additional Topics.
