Module 4 - Epidemiologic Study Designs 1:
Cohort Studies & Clinical Trials
Contents
Page 1
Introduction
Learning Objectives
Page 2
Overview of Epidemiologic studies
Page 3
Cohort Studies
Key Features of Cohort Studies
The Population "At Risk"
Page 4
Prospective Cohort Studies
Follow Up in Prospective Cohort Studies
Page 5
Retrospective Cohort Studies
Page 6
Prospective Versus Retrospective Cohort Studies
Strengths and Disadvantages
Prospective Cohort Studies
Retrospective Cohort Studies
Test Yourself
Page 7
Selection of Subjects for Cohort Studies
General Cohorts
Special Cohorts
Page 8
Selection of a Comparison Group
Test Yourself
Page 9
Basic Analysis of Cohort Study Data
Page 10
Analyzing Data in Subsets Using R
The tapply() command
An Alternate Method of Subset Analysis
Creating a Dichotomous Variable from a Continuous Variable
Crude Measures of Association in a Cohort Study (or Intervention Study)
Test Yourself
Page 11
Intervention Studies (Clinical Trials, Experimental Studies)
Ethical Considerations
Informed Consent
Page 12
Types of Intervention Studies
Therapeutic vs. Preventive
Individual Trials vs. Community Trials
Phases of Individual Therapeutic Trials
Phase 1 Clinical Trials
Phase 2 Clinical Trials
Phase 3 Clinical Trials
Page 13
The Physicians' Health Study on Aspirin
Enrollment
Page 14
Randomization and Blinding (Masking)
Randomization
Blinding
Page 15
Analysis of Clinical Trial Data
Test Yourself
Page 16
Strengths and Limitations of Clinical Trials
Strengths of Intervention Studies (Clinical Trials)
Limitations
Non-adherence
How to Promote Adherence in a Clinical Trial
Page 17
Data Safety and Monitoring Board
Intention-to-Treat Analysis versus Efficacy Analysis
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