Fundamentals of Clinical Trials is structured to address the fundamentals as the protocol for a clinical trial is being developed. A chapter is devoted to each of the critical areas of a protocol to aid the clinical trial researcher.

Contents

• Introduction to Clinical Trials
• What Is The Question?
• Study Population
• Basic Study Design
• The Randomization Process
• Blindness
• Sample Size
• Baseline Assessment
• Recruitment of Study Participants
• Data Collection and Quality Control
• Assessing and Reporting Adverse Effects
• Assessment of Health-Related Quality of Life
• Participant Adherence
• Survival Analysis
• Monitoring Response Variables
• Issues in Data Analysis
• Closeout
• Reporting and Interpreting of Results
• Multicenter Trials

  Index

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