临床试验设计的类型(1).pptxVIP

Lea Drye, PhD;?? 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;Lecture Outline;Comparison Structure: Parallel, Crossover, and Group;Parallel Design;;Parallel Design Example: NETT;Parallel Design Example: NETT;Crossover Design;Crossover De