Intervention Studies

Clinical Trials

Contents

Page 1
Introduction
Learning Objectives

Page 2
Types of Intervention Studies
Individual versus Group (Community) Trials
Prevention trials (or prophylactic trials) versus Therapeutic Trials
Phases of Trials Evaluating New Drugs

Page 3
The Subjects
Population Hierarchy
Internal and External Validity
Sample Size

Page 4
Assignment to Treatments or Regimens
Confounding
Methods of Assignment

Page 5
Blinding (Masking), Placebos, and Shams
The Placebo Effect

Page 6
Compliance and Loss to Follow Up
Effects of Non-compliance:
Ways to Maintain Compliance
Assessing Compliance
Loss to Follow Up

Page 7
Issues in the Analysis of Clinical Trials
The Basic Analysis
Did Randomization Control for Confounding?
Intention-to-Treat Analysis:
Efficacy Analysis

Page 8
Weighing Risk Versus Benefit

Page 9
The Cost of Prevention
"Number Needed to Treat"

Content ©2016. All Rights Reserved.
Date last modified: February 19, 2016.
Wayne W. LaMorte, MD, PhD, MPH

Boston University School of Public Health