Robert M. Califf MD


What We Mean When We Talk About EvGen Part II

By Rachel E. Sherman MD, MPH, & Robert M. Califf MD – Earlier, we discussed a pair of concepts – interoperability and connectivity – that are essential prerequisites for the creation of a successful national system for evidence generation. We take a look at how we would apply these constructs as we go about building such a system.


What We Mean When We Talk About EvGen Part I

By Rachel E. Sherman MD, MPH, & Robert M. Califf MD – Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current paradigm of generating the scientific evidence that supports medical product evaluation and clinical care decisions and the need to modernize methods and expectations surrounding this evidence base.


What We Mean When We Talk About Data

By Robert M. Califf MD & Rachel Sherman MD, MPH – Medical care and biomedical research are in the midst of a data revolution. Networked systems, electronic health records, electronic insurance claims databases, social media, patient registries, and smartphones and other personal devices together comprise an immense new set of sources for data about health and healthcare.


Why Partnerships are Key to the Science of Patient Input

By Nina L. Hunter PhD & Robert M. Califf MD – We recently announced the first FDA Patient Engagement Advisory Committee (PEAC), supported by the Center of Devices and Radiological Health (CDRH). The Committee will provide advice to the FDA Commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients.