#20: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know?

Overview

Real world evidence (RWE) has the potential to compliment and extend the safety and effectiveness knowledge of drugs gained from RCTs. This session will discuss key study design principles to guide evaluation of RWE using studies focused on cardiovascular safety assessments.

An additional registration fee is required for all preconference short courses.

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Who should attend?

This short course is designed for members of the Clinical Research and Regulatory audiences.

Learning objectives

At the conclusion of this course, participants should be able to:

Describe key epidemiological design principles central to interpreting the quality and validity of RWE studies
Apply these learnings by evaluating and discussing case presentations focused on CV safety assessments
Recognize when RWE based approaches are of sufficient quality to enable decision making

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Registration Questions?

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