This course will overview issues identified by students conducting clinical trials. It is expected that this course will meet the individual needs of enrolled students.

Objectives: 1) To identify individual needs of students conducting clinical trials. 2) To discuss certain topics such as: cluster randomization designs, cross-over designs, n-of-1 designs, group sequential and other adaptive designs, cost-effectiveness clinical trials, issues in sample size development, Bayesian trials, safety monitoring and interim analysis, composite endpoints, subgroup analysis. 3) To identify readings related to this topic. 4) To present the readings in a seminar format.