Duke-Margolis white paper explores fit-for-purpose patient-generated health data

A new white paper from the Duke-Margolis Real-World Evidence Collaborative provides insights on the use of patient-generated health data generated in real-world settings for regulatory decision-making. Building on a series of white papers on real-world evidence (RWE) published by the Duke Margolis Centre for Health Policy, the latest paper titled "Regulatory Fit-for-Purpose Considerations for Patient-Generated Health Data" explores the potential of patient-generated health data (PGHD) to address gaps in clinical trials and observational studies. The paper examines the characteristics of fit-for-purpose PGHD collected in real-world settings, emphasizing data relevance, reliability, and quality both broadly and across specific PGHD sources. It...