Three complementary innovations will be presented in an interactive discussion with a senior FDA official and the audience. The connecting thread is addressing unmet need and improving clinical outcomes by applying maturing science, new technologies, and partnerships to the therapeutic development and evaluation processes.

Learning Objectives:
Discuss how the Large Simple Trial (LST) compares to Conventional Phase 3 Trials (CP3T) in intent, design, conduct, interpretation, and use in clinical and regulatory decision making
Identify how an integrated, adaptive trial system can improve decision-making and identify and resolve trial and safety issues in near real time
Describe how successful data collection strategies and proposed novel approaches can support parallel development of therapeutic products and companion diagnostics.