
RWE Module 4: Study Design and Methodologies
Module Description
This module examines common real-world study designs and methodological considerations used to generate credible RWE. Learners will explore how study design, bias, and confounding affect the reliability of results and how to assess whether evidence is appropriate for coverage, utilization management, and contracting decisions.
Learning Objectives:
- Recognize the major types of real-world study designs (e.g., cohort, case control, cross-sectional) and when each is appropriate for payer decision-making.
- Review practical methods to control for bias and confounding.
- Describe the trade-offs between study rigor and real-world applicability and how they impact coverage, contracting, and clinical program decisions.
- Identify common pifalls in real-world studies that can weaken evidence used for formulary, utilization management, or value-based contracting.
Available Credit
- 1.00 Certificate of Completion

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