BookLawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger.
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.