Skip to main content

The US Food and Drug Administration and the Future of Cardiovascular Medicine.

Publication ,  Journal Article
Fiuzat, M; Califf, RM
Published in: JAMA Cardiol
November 1, 2016

Cardiovascular medicine has led the drive for creativity and innovation with a culture that has been at the forefront of evidence generation. However, we are functioning at only a fraction of our evidence generation capacity. Despite the leadership of cardiovascular medicine, very few guideline recommendations are supported by high levels of evidence, and the proportion of recommendations for which there is no conclusive evidence is substantial. Clinical research has proven to be too slow, unreliable, and expensive as conducted in the past. In the current era, a new model of unlimited information, better access to care, and better payer coverage has the potential to change our evidence base to support clinical guidelines. We now have the opportunity to use volumes of data to support US Food and Drug Administration labeling and practice guidelines. The electronic health record can be used to feed decisions and provide an information feedback loop. In addition, learning health systems can contribute to providing networks and registries for information sharing. In this Special Communication, we summarize opportunities of the cardiovascular community to build on its pioneering leadership in evidence-based medicine through major initiatives now under way. By joining in broad efforts to create an efficient national evidence generation system, larger proportions of clinical practice can be guided by high-quality evidence; clinicians and their practice organizations will be increasingly able to focus on interpreting, applying, and communicating research findings to improve outcomes; and patients and consumers will be increasingly informed and empowered to play active roles in managing their own health and health care.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

JAMA Cardiol

DOI

EISSN

2380-6591

Publication Date

November 1, 2016

Volume

1

Issue

8

Start / End Page

950 / 952

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Practice Guidelines as Topic
  • Leadership
  • Information Dissemination
  • Humans
  • Forecasting
  • Evidence-Based Medicine
  • Delivery of Health Care
  • Communication
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Fiuzat, M., & Califf, R. M. (2016). The US Food and Drug Administration and the Future of Cardiovascular Medicine. JAMA Cardiol, 1(8), 950–952. https://doi.org/10.1001/jamacardio.2016.2580
Fiuzat, Mona, and Robert M. Califf. “The US Food and Drug Administration and the Future of Cardiovascular Medicine.JAMA Cardiol 1, no. 8 (November 1, 2016): 950–52. https://doi.org/10.1001/jamacardio.2016.2580.
Fiuzat M, Califf RM. The US Food and Drug Administration and the Future of Cardiovascular Medicine. JAMA Cardiol. 2016 Nov 1;1(8):950–2.
Fiuzat, Mona, and Robert M. Califf. “The US Food and Drug Administration and the Future of Cardiovascular Medicine.JAMA Cardiol, vol. 1, no. 8, Nov. 2016, pp. 950–52. Pubmed, doi:10.1001/jamacardio.2016.2580.
Fiuzat M, Califf RM. The US Food and Drug Administration and the Future of Cardiovascular Medicine. JAMA Cardiol. 2016 Nov 1;1(8):950–952.

Published In

JAMA Cardiol

DOI

EISSN

2380-6591

Publication Date

November 1, 2016

Volume

1

Issue

8

Start / End Page

950 / 952

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Practice Guidelines as Topic
  • Leadership
  • Information Dissemination
  • Humans
  • Forecasting
  • Evidence-Based Medicine
  • Delivery of Health Care
  • Communication