Essentials of Clinical Research

Front Matter....Pages i-vi
The Beginning – Historical Aspects of Clinical Research, Clinical Research: Definitions, “Anatomy and Physiology,” and the Quest for “Universal Truth”....Pages 1-10
Introduction to Clinical Research Concepts, Essential Characteristics of Clinical Research, Overview of Clinical Research Study Designs....Pages 11-32
A Focus on Clinical Trials....Pages 33-74
Alternative Interventional Study Designs....Pages 75-90
Phase 4 (Postmarketing) Research....Pages 91-116
The Role of the USA Food and Drug Administration in Clinical Research....Pages 117-143
The Placebo and Nocebo Effect....Pages 145-176
Recruitment and Retention in Clinical Research....Pages 177-192
Data Safety and Monitoring Boards (DSMBs)....Pages 193-202
Meta-analysis, Evidence-Based Medicine, and Clinical Guidelines....Pages 203-231
Research Methods for Genetic Studies....Pages 233-256
Research Methods for Pharmacoepidemiology Studies....Pages 257-273
Implementation Research: Beyond the Traditional Randomized Controlled Trial....Pages 275-312
Research Methodology for Studies of Diagnostic Tests....Pages 313-326
Statistical Power and Sample Size: Some Fundamentals for Clinician Researchers....Pages 327-344
Association, Cause, and Correlation....Pages 345-362
Bias, Confounding, and Effect Modification (Interaction)....Pages 363-372
It’s All About Uncertainty....Pages 373-390
Grant and Manuscript Writing....Pages 391-418
The Media and Clinical Research....Pages 419-425
Mentoring and Advising....Pages 427-435
Presentation Skills: How to Present Research Results....Pages 437-447
Back Matter....Pages 449-461