Real-World Evidence — What Is It and What Can It Tell Us?
Rachel E. Sherman, Steven A. Anderson, Gerald J. Dal Pan, Gerry Gray, Thomas P. Gross, Nina L. Hunter, Lisa M. LaVange, Danica Marinac‐Dabic, Peter Marks, Melissa A. Robb, Jeffrey Shuren, Robert Temple, Janet Woodcock, Lilly Q. Yue, Robert M. Califf
Abstract
The FDA is developing guidance on the use of “real-world evidence” — health care information from atypical sources, including electronic health records, billing databases, and product and disease registries — to assess the safety and effectiveness of drugs and devices.
Topics & Concepts
Real world evidenceMedicineReal world dataHealth recordsElectronic health recordProduct (mathematics)Health careMEDLINEMedical emergencyHealth information technologyInternet privacyData scienceEconomic growthPolitical scienceEconomicsInternal medicineComputer scienceLawMathematicsGeometryHealth Systems, Economic Evaluations, Quality of LifeHealth Sciences Research and EducationPharmaceutical Economics and Policy