This module provides an overview of the primary design issues that must be considered by the many disciplines that collaborate on a clinical trial. We will consider the clinical, scientific, and regulatory setting of clinical trials, describing the phased approach to “treatment discovery” in which the safety, efficacy, and effectiveness of candidate treatments are investigated.

This one-day module focuses on the issues surrounding disease area and identification of the target population, definition of the treatment, choice of clinical outcomes, and choice of comparators. Throughout the instructors will emphasize pre-specification of these key elements in a well-defined study protocol.