The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices: What Have We Learned, Where Do We Need to Go?

David Holmes, Robert Hance, Tamara S. Syrek Jensen, Daniel A. Schwartz, Aaron Kaplan, Andrew Farb, Bram Zuckerman, Martin Leon, Jamie Waklowiak, Michael J. Mack, Jeff Shuren

Research output: Contribution to journalReview article

2 Scopus citations

Abstract

Performance of early feasibility studies in the United States can advance the goal of evaluating the safety and effectiveness of new devices aimed at unmet clinical needs and facilitating earlier access for U.S. patients to new technology. Early feasibility studies are an important component of the 21st Century Cures Act, enacted by Congress in 2016. Although regulatory processes have improved since the introduction of the Early Feasibility Studies Program, impediments at the hospital and clinical site level remain. In this paper, the authors review these issues and outline the structure and function of a clinical site consortium designed to address the problems and improve the U.S. clinical trial ecosystem.

Original languageEnglish (US)
Pages (from-to)2220-2225
Number of pages6
JournalJACC: Cardiovascular Interventions
Volume11
Issue number21
DOIs
StatePublished - Nov 12 2018

Keywords

  • early feasibility studies
  • unmet clinical needs in patients with structural heart disease

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Holmes, D., Hance, R., Syrek Jensen, T. S., Schwartz, D. A., Kaplan, A., Farb, A., Zuckerman, B., Leon, M., Waklowiak, J., Mack, M. J., & Shuren, J. (2018). The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices: What Have We Learned, Where Do We Need to Go? JACC: Cardiovascular Interventions, 11(21), 2220-2225. https://doi.org/10.1016/j.jcin.2018.05.010