340.645.01 INTRODUCTION TO CLINICAL TRIALS Introduces clinical
trial design in the context of epidemiological concepts, covers
various topics in the design and conduct of clinical trials, and
profiles clinical trials that illustrate these issues. Topics
include the definition and history of clinical trials; trial
designs, including phase I-IV, cross-over, factorial, and large,
simple designs; internal and external validity; controls,
randomization, and masking; ethical issues; data analysis
principles; monitoring of accumulating safety and efficacy data;
and use of data from randomized trials. Present the scientific
rationale for conducting clinical trials • Acquaint students
with various clinical trial designs • Provide an understanding
of randomization and of the principle of analysis by assigned
treatment • Familiarize students with ethical issues in clinical
trials and with related U.S. regulations and guidelines for the
conduct of trials • Illustrate topics with examples of clinical
trials - Monday 1:30