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Lea Drye, PhD
Johns Hopkins University
Types of Trial Design
Copyright © 2013 Johns Hopkins University and Lea Drye. All Rights Reserved.
Phase I:
First stage in testing a new intervention in humans
Usually 10-30 people
Identify tolerable dose, provide information on drug metabolism,
excretion, and toxicity
Often not controlled
Phase II:
Usually 30-100 people
Preliminary information on efficacy, additional information on
safety and side effects
Phase III:
Usually 100+ people
Assess efficacy and safety
Controlled, usually randomized
2
Phases of trials
Lecture Outline
Discuss various trial design types
Parallel
Crossover
Group allocation
Factorial
Large simple
Equivalency
Non-inferiority
Adaptive
3
Comparison Structure: Parallel, Crossover, and Group
Allocation Designs
Section A
The material in this video is subject to the copyright of the owners of the material and is being provided for educational purposes under rules of fair use for registered students in this course only. No additional copies of the copyrighted work may be made or distributed.
Parallel Design
5
Simultaneous treatment and control groups
Each person is randomly assigned to one treatment group
Randomization removes treatment selection bias and promotes comparability of treatment groups
Statistical comparisons made between treatment groups
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Randomized
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Parallel Design Example: NETT
Source: NETT Research Group (1999). Chest 1999; 116: 1750-61; NETT Research Group (1999). J Thorac Cardiovasc Surg, 118: 518-528; Fishman, A., Martinez, F., et al. (2003). N Engl J Med 348: 2059-73.
7
National Emphysema Treatment Trial (NETT)
- Phase III trial, unmasked
Population
People with severe emphysema
Sample size
1,200
Allocation to treatment
Randomized
Treatments
—Lung volume reduction surgery plus medical therapy
—Medical therapy (standard therapy control)
Parallel Design Example: NETT
Source: NETT Research Group (1999). Chest 1999; 116: 1750-61; NETT Resear
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