By Robert Califf – What we now call real-world data (RWD) have been used for years in medical product development to inform study design and endpoint selection, identify potential participants and trial sites, and assess safety in the post-marketing setting.
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By Robert M. Califf MD, MACC & Vid Desai – Technology and data have disrupted our world in ways unimaginable only 20 years ago – including how the world thinks about health. The COVID-19 pandemic accelerated these changes and underscored the importance of…
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.
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.
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.
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.
By Nina L. Hunter PhD & Robert M. Califf MD – Although it may seem odd in retrospect, the development of new technologies intended to improve patients’ lives has largely relied upon expert opinions rather than asking patients and families directly what they consider most important.