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 Citations (Scopus)

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

Fingerprint

Feasibility Studies
Equipment and Supplies
Ecosystem
Clinical Trials
Technology
Safety

Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices : What Have We Learned, Where Do We Need to Go? / Holmes, David; Hance, Robert; Syrek Jensen, Tamara S.; Schwartz, Daniel A.; Kaplan, Aaron; Farb, Andrew; Zuckerman, Bram; Leon, Martin; Waklowiak, Jamie; Mack, Michael J.; Shuren, Jeff.

In: JACC: Cardiovascular Interventions, Vol. 11, No. 21, 12.11.2018, p. 2220-2225.

Research output: Contribution to journalReview article

Holmes, D, Hance, R, Syrek Jensen, TS, Schwartz, DA, Kaplan, A, Farb, A, Zuckerman, B, Leon, M, Waklowiak, J, Mack, MJ & 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, vol. 11, no. 21, pp. 2220-2225. https://doi.org/10.1016/j.jcin.2018.05.010
Holmes, David ; Hance, Robert ; Syrek Jensen, Tamara S. ; Schwartz, Daniel A. ; Kaplan, Aaron ; Farb, Andrew ; Zuckerman, Bram ; Leon, Martin ; Waklowiak, Jamie ; Mack, Michael J. ; Shuren, Jeff. / The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices : What Have We Learned, Where Do We Need to Go?. In: JACC: Cardiovascular Interventions. 2018 ; Vol. 11, No. 21. pp. 2220-2225.
@article{5ab4c0b37e864a2b8bc05b2831ab5665,
title = "The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices: What Have We Learned, Where Do We Need to Go?",
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.",
keywords = "early feasibility studies, unmet clinical needs in patients with structural heart disease",
author = "David Holmes and Robert Hance and {Syrek Jensen}, {Tamara S.} and Schwartz, {Daniel A.} and Aaron Kaplan and Andrew Farb and Bram Zuckerman and Martin Leon and Jamie Waklowiak and Mack, {Michael J.} and Jeff Shuren",
year = "2018",
month = "11",
day = "12",
doi = "10.1016/j.jcin.2018.05.010",
language = "English (US)",
volume = "11",
pages = "2220--2225",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "21",

}

TY - JOUR

T1 - The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices

T2 - What Have We Learned, Where Do We Need to Go?

AU - Holmes, David

AU - Hance, Robert

AU - Syrek Jensen, Tamara S.

AU - Schwartz, Daniel A.

AU - Kaplan, Aaron

AU - Farb, Andrew

AU - Zuckerman, Bram

AU - Leon, Martin

AU - Waklowiak, Jamie

AU - Mack, Michael J.

AU - Shuren, Jeff

PY - 2018/11/12

Y1 - 2018/11/12

N2 - 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.

AB - 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.

KW - early feasibility studies

KW - unmet clinical needs in patients with structural heart disease

UR - http://www.scopus.com/inward/record.url?scp=85055664336&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85055664336&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2018.05.010

DO - 10.1016/j.jcin.2018.05.010

M3 - Review article

C2 - 30409280

AN - SCOPUS:85055664336

VL - 11

SP - 2220

EP - 2225

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

SN - 1936-8798

IS - 21

ER -