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An expert considers the buildup of cardiovascular and cardiometabolic innovation, and the role of regulatory delays in it.
The Metabolic Institute of America’s (TMIOA) 2021 Heart in Diabetes sessions in New York, NY this weekend highlighted the booming fields of research propelling the collaborative fields of cardiovascular, metabolic, and renal disease care.
Discussions throughout the meeting mainly focused on the advancement such research could deliver to clinical practice in the US. There was, however, underlying themes fixed on real-world delays. Presentations and reviews, at times, touched on a recurring theme: does the US health care system have a buildup of therapeutic indications because discovery outpaces deliberation?
In an interview with HCPLive during the meeting, Christie Ballantyne, MD, Director of the Center for Cardiometabolic Disease Prevention at Baylor College of Medicine, discussed the possible issues his field sees in the rate of innovation and research relative to the process of regulation.
One such example he noted was the the awaited US FDA indication for promising investigative therapy inclisiran. Though part of its regulatory delay was due to inspection incapabilities brought on by the COVID-19 pandemic, it may also be at a detriment in real-world application because of US health care systems’ lessened value of lipid management in would-be eligible patients.
“There are some things we need to address in regards to implementation science to improve quality of care, which is just as important as making new therapies,” Ballantyne said.
Ballantyne also discussed the “disappointing” nature of new trial evidence lagging behind US real-world application datasets, and the need to better wield currently available therapies while awaiting ones yet to become authorized.
“Let’s work hard on the other things,” Ballantyne said. “Just because you can’t control one thing, it just means you’ll have to work harder on everything else.”