Cardiologists should take advantage of new tools available for collecting high-quality data, according to the head of the FDA.
“We are now entering a new era in medicine that is characterized by dramatic accelerations in biological and information sciences and near-ubiquitous uptake of social media and personal devices,” Robert M. Califf, MD, commissioner of food and drugs at the agency, wrote online in the Journal of the American College of Cardiology.
“The FDA is responding to this changing world. However, we believe the needed changes must involve not only the FDA but the entire ecosystem of which the FDA is a part. As we work together to shape the future of medicine, cardiovascular specialists will play a special role.”
With a minority of guidelines actually supported by high-quality evidence — 15%, Califf estimated — the cardiovascular community can do better. “Dramatic improvements in the rate, quantity, and quality of evidence generation are within reach. Almost all Americans now have electronic health records, and social media combined with wearable devices are opening new frontiers in patient- and population-level data,” he wrote, adding that registries are “proliferating.”
The collection of complex individual measurements — heart rate, heart rhythm, blood pressure, and other metrics — may contribute to the phenotyping of cardiovascular disease and may also help pin down the value of biomarkers, Califf added.
“When combined with modern informatics and computing resources, this rich tapestry of information will enable a true paradigm shift, replacing the ‘one biomarker at a time’ approach with algorithms that integrate multiple measures to predict outcomes, diagnose and classify disease, and tailor treatment to the individual.”
He added that data is also sorely needed for underserved populations like neonates, pregnant women, and the elderly. What’s more, little remains known about why access and adherence to cardiovascular medicine is limited in low-income communities.
For the FDA’s part, the agency is developing a new way to approve and monitor device safety by pulling together electronic health records, insurance claims, and registries, according to its head. Medicare already mandates such data collection in post-marketing registries for procedures such as left atrial appendage closure under the “coverage with evidence development” system.
Califf reported relationships — prior to his appointment to the FDA — with Amylin, Eli Lilly, Bristol-Myers Squibb, Janssen Research and Development, Merck, Novartis, Amgen, Bayer Healthcare, BMEB Services, Genentech, GlaxoSmithKline, Heart.org, Daiichi-Sankyo, Kowa, Les Laboratories Servier, Medscape/Heart.org, Regado, Roche, N30 Pharma, and Portola.
Journal of the American College of Cardiology
Califf RM “The future of cardiovascular medicine from the regulatory perspective” J Am Coll Cardiol 2016; DOI: 10.1016/j.jacc.2016.07.001.