This course covers current issues in the design and analysis of randomized clinical trials (RCTs). It is part of the Biostatistical Methods in Clinical Research series, continuing on from Biostatistical Methods IV (BIOSTAT 210), covering additional biostatistical methods and allowing more in-depth exploration of the topics of Biostatistical Methods II (BIOSTAT 208) and Biostatistical Methods III (BIOSTAT 209).
In the healthcare setting, randomized controlled trials (RCTs) are experiments in which investigators randomly assign eligible patients into intervention groups, and then compare the outcomes of the groups to determine the relative effect of the intervention. The primary outcome variable in such trials is typically a measure of ultimate clinical status, such as disease progression. In this course, we will examine study design and analysis methods that have been developed to ensure the validity of the results of RCTs.
By the end of the course, students will have:
- a working knowledge of a variety of classical and adaptive study designs for clinical trials;
- understood the methods behind interim monitoring of Phase III trials;
- be able to design a superiority or noninferiority trial for binary responses; and
- understood concepts behind Bayesian designs and analyses.
- Instructor: Joan Hilton
- Instructor: Chuck Mcculloch