Learning : Short Courses
Learning : Short Courses
The Design and Monitoring of Group Sequential Clinical Trials
Daniel L. Gillen, PhD and John M. Kittelson, PhD
August, 2013
Abstract: In this module we provide an introduction to methodology for the design, monitoring and analysis of group sequential trials. The module will present and illustrate methods for adaptive trial design that maintain pre-specified trial operating characteristics. Methodology will be presented using case studies and examples of clinical trials with continuous, binary, and survival endpoints. The sequential methods will be illustrated using RCTdesign, an R module for the design, monitoring, and analysis of clinical trials. Emphasis will be placed on both the scientific and statistical impact of group sequential trial design.
Course Handouts (pdf):
R Code to Produce the Results in Each Handout:
Course Exercises and R Code Solutions: