Author + information
- Received March 5, 2018
- Revision received May 3, 2018
- Accepted May 8, 2018
- Published online November 5, 2018.
- David R. Holmes Jr., MDa,∗ (, )
- Robert Hance, BS, MBAb,
- Tamara S. Syrek Jensen, JDc,
- Daniel A. Schwartz, BA, BSb,
- Aaron Kaplan, MDd,
- Andrew Farb, MDe,
- Bram Zuckerman, MDe,
- Martin Leon, MDf,
- Jamie Waklowiak, JDg,
- Michael J. Mack, MDg and
- Jeff Shuren, MDe
- aDepartment of Cardiology, Mayo Clinic, Rochester, Minnesota
- bMedical Device Innovation Consortium, Arlington, Virginia
- cCenters for Medicare & Medicaid Services, Baltimore, Maryland
- dLebanon Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
- eU.S. Food and Drug Administration, Silver Spring, Maryland
- fColumbia University Medical Center, New York, New York
- gBaylor Scott and White Health, Dallas, Texas
- ↵∗Address for correspondence:
Dr. David R. Holmes, Jr., Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905.
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.
Drs. Shuren, Zuckerman, and Farb are employees of the U.S. Food and Drug Administration. Dr. Syrek Jensen is an employee of the Centers for Medicare and Medicaid Services. Mr. Schwartz and Mr. Hance are employees of the Medical Device Innovation Consortium. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 5, 2018.
- Revision received May 3, 2018.
- Accepted May 8, 2018.
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