Mitchell A Psotka, Mona Fiuzat, Peter E Carson, David P Kao, Jeffrey Cerkvenik, Daniel E Schaber, Patrick Verta, Robert T Kazmierski, Meir Shinnar, Norman Stockbridge, Ellis F Unger, Bram Zuckerman, Javed Butler, G Michael Felker, Marvin A Konstam, JoAnn Lindenfeld, Scott D Solomon, John R Teerlink, Christopher M O'Connor, William T Abraham
The development of treatments for heart failure (HF) is challenged by burdensome clinical trials. Reducing the need for extensive data collection and increasing opportunities for data compatibility between trials may improve efficiency and reduce resource burden. The Heart Failure Collaboratory (HFC) multi-stakeholder consortium sought to create a lean case report form (CRF) for use in HF clinical trials evaluating cardiac devices. The HFC convened patients, clinicians, clinical researchers, the U.S. Food and Drug Administration (FDA), payers, industry partners, and statisticians to create a consensus core CRF...
August 2, 2019: JACC. Heart Failure