This course is an introduction to the fundamental statistical issues in designing clinical research studies. Its primary emphasis is on understanding the design and analytic methods of clinical research from a statistical perspective. Lectures and discussions will focus on the following: exploratory data analysis, basic concepts of statistical analysis, construction of hypothesis tests and confidence intervals, the development of statistical methods for analyzing data, development of mathematical models used to relate a response variable to explanatory or descriptive variables, and an introduction to statistical analysis of microarray and genomic studies.