临床试验设计的类型参考课件.pptVIP

2 * Lea Drye, PhD Johns Hopkins University Types of Trial Design Copyright ? 2013 Johns Hopkins University and Lea Drye. All Rights Reserved. 2 * ?? 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 2 * Lecture Outline