Pragmatic Studies for Real World Evidence – Lifting the Veils

Date	Mar 17, 2016
Time	11:00 AM EDT
Cost	Free
Online

This webinar describes and explains pragmatic studies and discusses why key Late Stage stakeholders are increasingly interested in pragmatic studies – and why, nevertheless, pragmatic approaches are still relatively rare in the area of RWE. The panel outlines operational modifications and adaptations of the main pragmatic study approach, such as community based studies, cluster randomized approaches, and ‘stepped wedge’ designs.
The panel also discusses both current and future regulatory considerations such as the new EU Clinical Trials Regulation. An outlook into the future of pragmatic study types will be provided, and strategic options for potential design modifications will be assessed. We will close our evaluation of pragmatic studies and their nuances by assessing evidence validity from pragmatic approaches with others, primarily analytic methods minimizing bias in observational settings.
Learning Objectives

• What do we mean by ‘Real World Evidence’?
• Understand RWE needs of Late Stage stakeholders
• Understand why stakeholders are asking for pragmatic approaches and why they are still rarely performed
• Understand internal / external validity and efficacy vs. effectiveness
• Discuss nuances of pragmatic approaches such as cluster randomization, community based designs, or stepped wedge approaches
• Learn about the regulatory considerations when planning and conducting pragmatic studies
• Understand analytic considerations for evidence validity in pragmatic designs, versus non-interventional approaches using analytic techniques such as regression methods, propensity score matching, instrumental variables.