STAT 4025 - Clinical Trial Design

3 Class Hours 0 Laboratory Hours 3 Credit Hours
Prerequisite: STAT 3125 or STAT 3120.
The course introduces students to statistical concepts upsed to design clinical trials, or randomized studies of humans. Students will be able to design, conduct, and analyze clinical trials in the format required by the Food and Drug Administration. The topics include endpoint definition, sources of bias, randomization schemes, types of blindness, phases of clinical studies (I-IV), hypothesis formation, sample size determination, patient recruitment, adverse events, and protocol development.