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J Am Coll Cardiol. 2015 Apr 21;65(15):1567-82. doi: 10.1016/j.jacc.2015.03.016.

Cardiovascular drug development: is it dead or just hibernating?

Author information

1
Duke Clinical Research Institute, Durham, North Carolina. Electronic address: christopher.fordyce@duke.edu.
2
Duke Clinical Research Institute, Durham, North Carolina.
3
Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
4
State University of New York Downstate Medical Center, Brooklyn, New York.
5
University of Colorado School of Medicine, Aurora, Colorado.
6
Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas.
7
Amgen, Inc., Thousand Oaks, California.
8
Regeneron Pharmaceuticals, Tarrytown, New York.
9
University of Michigan School of Medicine, Ann Arbor, Michigan.
10
University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
11
National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
12
Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
13
Bayer HealthCare Pharmaceuticals, Whippany, New Jersey.
14
The Medicines Company, Parsippany, New Jersey.
15
Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland.

Abstract

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.

KEYWORDS:

biomarkers; cardiovascular agents; clinical trials; drug costs; pharmacological; policy

PMID:
25881939
DOI:
10.1016/j.jacc.2015.03.016
[Indexed for MEDLINE]
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