The Design and Monitoring of Group Sequential Clinical Trials
Event Information
About this event
Who should attend?
Any faculty, students, or staff researchers who have an interest in learning about different adaptive clinical trial designs. Theory of sequential testing will not be the focus of the course, but some experience in the statistical design of randomized clinical trials is helpful but not required
Summary of course:
This course provides an introduction to the methodology for the design, monitoring and analysis of group sequential trials. 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.
About the course:
Increasingly, clinical trials are conducted using group sequential methods in order to address the ethical and efficiency requirements for 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. In this course I 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 RCTdesgn, 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. Theory of sequential testing will not be the focus of the course, but some experience in the statistical design of randomized clinical trials will be helpful.
Organizer Center for Statistical Consulting & ICTS - BERD
Organizer of The Design and Monitoring of Group Sequential Clinical Trials
