Content by Robert M. Califf, Nina L. Hunter
Combination Products Review ProgramProgress and potential report
Tue, 01/17/2017 - 12:01
About a year ago, we shared with you our combination product review, Intercenter Consult Process Study Report, developed by the U.S. Food and Drug Administration’s (FDA) Office of Planning. The report findings were derived from focus group studies… What We Mean When We Talk About EvGen, Part 2Building out a national system for evidence generation
Tue, 05/24/2016 - 14:30
In an earlier article, we discussed a pair of concepts—interoperability and connectivity—that are essential prerequisites for creating a successful national system for evidence generation (or “EvGen”). Here, we take a look at how we would apply… What We Mean When We Talk About EvGen, Part 1Laying the foundation for a national system for clinical evidence generation
Thu, 04/28/2016 - 12:23
Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks… What We Mean When We Talk About ‘Data’FDA defines some terms
Thu, 01/07/2016 - 16:04
Medical care and biomedical research are in the midst of a data revolution. Put together, networked systems, electronic health records, electronic insurance claims databases, social media, patient registries, and personal devices comprise an…
