Robert M. Califf
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...
Robert M. Califf
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 “...
Robert M. Califf
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...
Robert M. Califf
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...