Design, Monitoring, Analysis of Clinical Trials

Scott S. Emerson, MD, PhD

October, 2009

Abstract: Increasingly, clinical trials are conducted using group sequential methods in order to address the ethical and efficiency issues that arise when performing experiments with human volunteers. The design, conduct, and analysis of a sequential clinical trial is necessarily more involved than that for a clinical trial in which the data would only be analyzed at the end of the study. However, the basic tenets of careful consideration of the scientific question and clinical setting remains the same. In this short course we present an overview of the issues that must be considered when conducting a group sequential trial.