Course Description
Drug development and FDA approval procedures; randomization; blindness; phase I-IV clinical trials; multicenter trials; bioequivalency; sample size determination; design and analysis; cross-over design; repeated measurements design; survival analysis; meta analysis.
Athena Title
CLINICAL TRIALS
Prerequisite
STAT 6320 or STAT 6420 or BIOS 7020
Semester Course Offered
Offered fall
Grading System
A - F (Traditional)
Course Objectives
Upon completion of the course, students will know the stages of the drug development and testing process and the steps of drug approval by the US FDA. They will become familiar with experimental design issues that arise in clinical trials such as randomization, double-blinding, sample size determination and power analysis, and the use of cross-over, multicenter, repeated measures and adaptive designs. Students will understand how to implement, interpret and report the results of methods of statistical analysis applicable to clinical trials including survival analysis and meta-analysis. They will understand many of the practical issues that arise in the conduct of clinical trials including recruitment of subjects, data collection, data confidentiality, and maintaining adherence to study protocols.
Topical Outline
Drug development and FDA approval procedures; randomization; blindness; phase I-IV clinical trials; multicenter trials; bioequivalency; sample size determination; design and analysis; cross-over design; repeated measurements design; survival analysis; meta analysis.