Improving Cardiovascular Drug and Device Development and Evidence Through Patient-Centered Research and Clinical Trials: A Call to Action From the Value in Healthcare Initiative's Partnering With Regulators Learning Collaborative.

Circulation. Cardiovascular Quality and Outcomes
John J WarnerAmerican Heart Association Partnering with Regulators Learning Collaborative*

Abstract

The pipeline of new cardiovascular drugs is relatively limited compared with many other clinical areas. Challenges causing lagging drug innovation include the duration and expense of cardiovascular clinical trials needed for regulatory evaluation and approvals, which generally must demonstrate noninferiority to existing standards of care and measure longer-term outcomes. By comparison, there has been substantial progress in cardiovascular device innovation. There has also been progress in cardiovascular trial participation equity in recent years, especially among women, due in part to important efforts by Food and Drug Administration, National Institutes of Health, American Heart Association, and others. Yet women and especially racial and ethnic minority populations remain underrepresented in cardiovascular trials, indicating much work ahead to continue recent success. Given these challenges and opportunities, the multistakeholder Partnering with Regulators Learning Collaborative of the Value in Healthcare Initiative, a collaboration of the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University, identified how to improve the evidence generation process for cardiovascular drugs an...Continue Reading

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Citations

Nov 24, 2020·Current Treatment Options in Cardiovascular Medicine·Sujana BallaFatima Rodriguez
Mar 16, 2021·European Heart Journal·Andrea CaporaliMaurizio Scaltriti
Jul 21, 2020·Circulation. Cardiovascular Quality and Outcomes·Karen E Joynt MaddoxMadeleine Konig

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