Real-World Evidence

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.

An Introduction to Real-World Data & Real-World Evidence: A Virtual Training Series for the Patient Community

The National Health Council and our partners at the Duke-Margolis Center for Health Policy are pleased to announce a new webinar series: An Introduction to Real-World Data & Real-World Evidence! The series, which is free and open to the public, will continue through March 2021. Learn more here.

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

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.

Improving the Use of Patient-Provided Information in Real-World Evidence Research

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.

CMSS-NHC Primer: Enhancing Patient Partnerships in Clinical Registries and Research

How Patient Organizations and Medical Societies Can Enhance Patient Engagement in Clinical Registries and Research

View it here.

Engaging Patients in Real-World Evidence: An Atrial Fibrillation Patient Advisory Board Case Example

In 2019, the Pfizer–Bristol Myers Squibb Alliance partnered with the National Health Council and the Arrhythmia Alliance to engage with people diagnosed with atrial fibrillation (AF). Through an advisory board, they sought to understand patient perspectives and enhance patient centricity for future AF Real-World Data studies in the short term and AF Real-World Evidence in the long term. The approaches and learnings from this process are presented in this publication, and it serves as a case study for researchers interested in engaging patients on RWE for other clinical conditions.

Read the paper here.

Recent Presentations

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.
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 June 2020, Dr. Elisabeth Oehrlein was interviewed by The Evidence Base. She discussed the importance of patient engagement and leveraging patient-provided information to improve real-world evidence. Read about the interview here.
Dr. Elisabeth Oehrlein was a panelist at the Duke-Margolis Center for Health Policy’s virtual event, Developing Study Endpoints in Real-World Settings, in December 2020. At the third session titled, Policy Implications for Advancing the Acceptability of Real-World Endpoints, Dr. Oehrlein discussed the importance of selecting outcomes that are meaningful to patients. Watch the event here.