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Introduction to Study Design

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Getting Started
Overview

1 Quiz
- Exercises: Overview
Measures of Disease Occurrence & Association

5 Topics
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1 Quiz
- Exercises: Measures of occurrence & association
Trials & Meta-Analyses

4 Topics
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1 Quiz
- Exercises: Trials & meta-analyses
Observational Studies

4 Topics
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1 Quiz
- Exercises: Observational studies
Bias

3 Topics
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1 Quiz
- Exercises: Bias
Confounding

3 Topics
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1 Quiz
- Exercises: Confounding
References
Additional Resources

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Exercises: Trials & meta-analyses

Introduction to Study Design
Trials & Meta-Analyses
Exercises: Trials & meta-analyses

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Question 1 of 2

1. Question

Match each of the following trials with the correct drug trial phase:

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A trial examined the safety, tolerability and pharmacokinetic profile of a new drug in 14 health volunteers.
The safety profile and metabolic effects of treatment with an investigational drug were examined in a randomized controlled trial which included 200 patients with diabetes.
A multicentre, randomized, double-blind study of 2,500 patients with diabetes found that a new treatment for diabetes was associated with a lower risk of heart attacks than a standard treatment.
Following market approval of a drug, a trial was conducted to study the incidence of adverse events following long-term use.

Phase 1

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Phase 2

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Phase 3

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Phase 4

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Question 2 of 2

2. Question

Match each scenario with a concept of trial design.

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Although some patients stopped taking the tested drug before the trial ended, researchers conducted an analysis based on the treatment groups each patient was assigned to at the outset of the trial.
Researchers were interested in whether a vitamin supplement or drug therapy might protect against heart disease, so they first randomized all patients to a vitamin supplement or placebo and then randomized all patients to the drug therapy or placebo.
When a study of a new pain drug was conducted, measures were taken to try to ensure that patients were unaware of whether they had received the new drug or standard therapy so that it would not affect their assessment of treatment.
Patients enrolled in a trial of a new treatment for hypertension were equally likely to receive either the new treatment or standard therapy, but the assignment of treatment was not based on how advanced their hypertension was.

Intention-to-treat analysis

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Factorial design

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Blinding

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Randomization

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