1、Lea Drye, PhD,Johns Hopkins University,Types of Trial Design,Copyright 2013 Johns Hopkins University and Lea Drye. All Rights Reserved.,1,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

2、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,2,Lecture Outline,Discuss various trial des

3、ign types Parallel Crossover Group allocation Factorial Large simple Equivalency Non-inferiority Adaptive,3,3,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 f

4、or 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.,4,Parallel Design,5,Simultaneous treatment and control groups Each person is randomly assigned to one treatment group Randomization re

5、moves treatment selection bias and promotes comparability of treatment groups Statistical comparisons made between treatment groups,|,P,叫,eG,巾,Randomized,占v,1，白,6,iJHSPH,Parallel Design Example: NETT,Source: NETT Research Group (1999). Chest 1999; 116: 1750-61; NETT Research Group (1999). J Thorac C

6、ardiovasc Surg, 118: 518-528; Fishman, A., 116: 1750-61; NETT Research Group (1999). J Thorac Cardiovasc Surg, 118: 518-528; Fishman, A., 1(8491):1169-73,Population Preschool children in northern Sumatra in 1982-83 Treatments Vitamin A supplementation during study Vitamin A supplementation after study Clusters Vi