4th Summer Institute in Statistics for Clinical Research

Module 5: Introduction to Clinical Trials II: Conduct and Implementation

Session 2, Tuesday 8:30 AM - 5:00 PM: Tue Jul 25

This module presents topics regarding the conduct and implementation of clinical trials that build upon the key concepts introduced in the Module 1: Introduction to Clinical Trials I: Design. Participants in this module are encouraged to take Module 1: Introduction to Clinical Trials I: Design, although this is not required for participants who believe they have the necessary background.

This one-day module focuses on choice of randomization strategies, blinding, specification of secondary endpoints, handling of missing data, study conduct and monitoring, the role of an independent data monitoring committee, and plans for reporting of the result. Throughout the module the instructors emphasize pre-specification of these elements in a well-defined study protocol.