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The topic of real-world evidence (RWE) has gained considerable attention recently. As health researchers, policymakers, and regulators establish standards and structure for using real-world data (RWD) as evidence in regulatory and clinical decision making, patients must be the primary focus. Since the idea of RWD is new to many in the patient community, it is important to explore the patient community’s needs, concerns, and protentional contributions and use of RWE to ensure the patient voice is considered.

Publications

Patient-community Perspectives on Real-World Evidence: Enhancing Engagement, Understanding, and Trust:

This paper discusses the findings of a day-long, multi-stakeholder roundtable held on July 31, 2017 that focused on the patient-community views on Real-World Evidence.

Methods & Principles

This ongoing project seeks to understand how patient-provided information (PPI) - gathered through meaningful patient engagement - can be translated by researchers into more patient-centered real-world data (RWD) research designs that reflect patients’ lived experiences.

Presentations

  • Dr. Elisabeth Oehrlein presented at ISPOR, New Orleans: Leveraging Patient-Provided Information to Improve RWE: Getting to Good Practices on How in May 2019. View the slides: Part 1, Part 2, Part 3.

  • In January 2019, Dr. Eleanor Perfetto spoke in a webinar with Jennifer Graff, Brande Yaist, and Tricia Lee Wilkins the FDA Framework for Real-World Evidence. You can access the webinar here.