Fundamentals of Clinical Trials

• Main Authors: Friedman, Lawrence M. (Author), Furberg, Curt D. (Author), DeMets, David L. (Author), Reboussin, David M. (Author), Granger, Christopher B. (Author)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Springer, 2015.
• Edition: 5th ed. 2015.
• Subjects: Statistics.; Cancer research.; Public health.; Oncology.; Epidemiology.; Statistics for Life Sciences, Medicine, Health Sciences.; Public Health.; Cancer Research.

This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. Most chap...

Table of Contents:

• Introduction to Clinical Trials
• Ethical Issues
• What is the Question?
• Study Population
• Basic Study Design
• The Randomization Process
• Blinding
• Sample Size
• Baseline Assessment
• Recruitment of Study Participants
• Data Collection and Quality Control
• Assessment and Reporting of Harm
• Assessment of Health Related Quality of Life
• Participant Adherence
• Survival Analysis
• Monitoring Committee Structure & Function
• Statistical Methods Used in Interim Monitoring
• Issues in Data Analysis
• Closeout
• Reporting and Interpreting of Results
• Multicenter Trials
• Regulatory Issues.