Dockets Management Staff Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane, Rm.1061 Rockville, MD 20852 RE: FDA Guidance, “Real-World Data: Assessing Electronic Health Records and […]
Real World Evidence
NHC Comments on PDUFA Reauthorization Performance Goals and Procedures FY 2023-2027
PDF Version October 28, 2021 Janet Woodcock, MD Acting Commissioner US Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 RE: PDUFA Reauthorization Performance Goals and Procedures […]
GUEST BLOG: Will the 21st Century Cures Act 2.0 Deliver Innovation and Health Breakthroughs for Post-Infection Diseases?
GUEST BLOG: Will the 21st Century Cures Act 2.0 Deliver Innovation and Health Breakthroughs for Post-Infection Diseases? By Emily Taylor, Solve M.E. Director of Advocacy and Community Relations Five years […]
Current Landscape of Patient-Generated Data and Data Privacy
Current Landscape of Patient-Generated Data and Data Privacy By: Sara Gray, Programs Associate Last December, the National Health Council and Duke-Margolis hosted the fourth webinar in the Real-World Evidence (RWE) […]
Patient-Centered Real-World Evidence: Consensus Recommendations & Use Cases
Patient-Centered Real-World Evidence: Consensus Recommendations & Use Cases Event Time: 10:00 – 11:00 a.m. ET Event Location: Virtual Moderator: Rachele Hendricks-Sturrup, DHSc, Research Director, Real-World Evidence, Duke-Margolis Center for Health […]
How Can Researchers Develop Patient-Centered Real-World Evidence?
How Can Researchers Develop Patient-Centered Real-World Evidence? By Elisabeth M. Oehrlein, PhD, MS, Assistant Vice President, Research and Programs Why is this important? Interest in real-world data (RWD) and real-world evidence (RWE) […]
Recent NHC Staff Presentations and Interviews About Real-World Evidence and Real-World Data
Recent NHC Staff Presentations and Interviews About Real-World Evidence and Real-World Data In May 2021, Dr. Elisabeth Oehrlein presented at the National Academy workshop, Building Data Capacity for Patient-centered Outcomes […]
Real-World Evidence Glossary
Real-World Evidence Glossary How This Glossary Was Developed The terms selected for inclusion in this glossary were identified based on a targeted literature review and in the expertise of NHC and Duke-Margolis staff and expert advisors. The following process was used: […]
Sources of Real-World Data: An Introduction to Patient Registries
Webinar Summary: Sources of Real-World Data: An Introduction to Patient Registries By Sara Gray, Associate, Research & Programs The National Health Council and the Duke-Margolis Center for Health Policy continued the introductory […]
Webinar Summary: Sources of Real-World Data (RWD) – An Introduction to “Big Data”
Webinar Summary: Sources of Real-World Data (RWD) – An Introduction to “Big Data” By Sara Gray, Associate, Programs On Nov. 6, 2020, the National Health Council (NHC) along with our partners at the […]