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Cardiovascular drug development: is it dead or just hibernating?

Publication ,  Journal Article
Fordyce, CB; Roe, MT; Ahmad, T; Libby, P; Borer, JS; Hiatt, WR; Bristow, MR; Packer, M; Wasserman, SM; Braunstein, N; Pitt, B; DeMets, DL ...
Published in: J Am Coll Cardiol
April 21, 2015

Despite the global burden of cardiovascular disease, investment in cardiovascular drug development has stagnated over the past 2 decades, with relative underinvestment compared with other therapeutic areas. The reasons for this trend are multifactorial, but of primary concern is the high cost of conducting cardiovascular outcome trials in the current regulatory environment that demands a direct assessment of risks and benefits, using clinically-evident cardiovascular endpoints. To work toward consensus on improving the environment for cardiovascular drug development, stakeholders from academia, industry, regulatory bodies, and government agencies convened for a think tank meeting in July 2014 in Washington, DC. This paper summarizes the proceedings of the meeting and aims to delineate the current adverse trends in cardiovascular drug development, understand the key issues that underlie these trends within the context of a recognized need for a rigorous regulatory review process, and provide potential solutions to the problems identified.

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

April 21, 2015

Volume

65

Issue

15

Start / End Page

1567 / 1582

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Humans
  • Government Regulation
  • Federal Government
  • Drug Industry
  • Drug Discovery
  • Drug Approval
  • Congresses as Topic
  • Clinical Trials as Topic
 

Citation

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Fordyce, C. B., Roe, M. T., Ahmad, T., Libby, P., Borer, J. S., Hiatt, W. R., … Califf, R. M. (2015). Cardiovascular drug development: is it dead or just hibernating? J Am Coll Cardiol, 65(15), 1567–1582. https://doi.org/10.1016/j.jacc.2015.03.016
Fordyce, Christopher B., Matthew T. Roe, Tariq Ahmad, Peter Libby, Jeffrey S. Borer, William R. Hiatt, Michael R. Bristow, et al. “Cardiovascular drug development: is it dead or just hibernating?J Am Coll Cardiol 65, no. 15 (April 21, 2015): 1567–82. https://doi.org/10.1016/j.jacc.2015.03.016.
Fordyce CB, Roe MT, Ahmad T, Libby P, Borer JS, Hiatt WR, et al. Cardiovascular drug development: is it dead or just hibernating? J Am Coll Cardiol. 2015 Apr 21;65(15):1567–82.
Fordyce, Christopher B., et al. “Cardiovascular drug development: is it dead or just hibernating?J Am Coll Cardiol, vol. 65, no. 15, Apr. 2015, pp. 1567–82. Pubmed, doi:10.1016/j.jacc.2015.03.016.
Fordyce CB, Roe MT, Ahmad T, Libby P, Borer JS, Hiatt WR, Bristow MR, Packer M, Wasserman SM, Braunstein N, Pitt B, DeMets DL, Cooper-Arnold K, Armstrong PW, Berkowitz SD, Scott R, Prats J, Galis ZS, Stockbridge N, Peterson ED, Califf RM. Cardiovascular drug development: is it dead or just hibernating? J Am Coll Cardiol. 2015 Apr 21;65(15):1567–1582.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

April 21, 2015

Volume

65

Issue

15

Start / End Page

1567 / 1582

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Humans
  • Government Regulation
  • Federal Government
  • Drug Industry
  • Drug Discovery
  • Drug Approval
  • Congresses as Topic
  • Clinical Trials as Topic