Using real-world data as scientific evidence

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 potential contributions and use of RWE to ensure the patient voice is considered.

In January 2020, the National Health Council, in partnership with the Duke-Margolis Center for Health Policy, launched a new project to develop and deliver a training program and relevant tools to be used, adapted, and updated to expand patient-community capacity to engage in real-world evidence (RWE) research, especially comparative effectiveness research. Over the coming year and a half, we will be hosting an in-person training, as well as developing online modules and other resources.

Thank you to our Advisory Committee Members.

If you would like to be added to our RWE mailing list, please contact [email protected].

This program is funded through a Patient-Centered Outcomes Research Institute® (PCORI®) Eugene Washington PCORI Engagement Award (16203-NHC).

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 potential contributions and uses of RWE to ensure the patient voice is considered. 

Read the paper.

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. Learn more here.

  • 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 1Part 2Part 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.

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