临床试验设计的类型(1)PPT课件.pptx

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 parability of treatment groups
 parisons made between treatment groups
|
P
叫
ωe G
巾
Randomized
「占v
1,白
6
iJHSPH
Crossover Design
9
 Randomization of order in which treatments are received
AB or BA
Randomization promotes balance between treatment groups in
timing of exposure
 Testing of both treatments in each patient
Each patient serves as his/her own control
Variability reduced because less variability within patient than
between patients
 Fewer patients needed
Crossover Design Graph
Washout
10
Group 1, Tx A
Group 1, Tx B
Group 2, Tx B
Group 2, Tx A