Cardiovascular Drug Development

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:65

Review

Fordyce, Christopher B.¹  Roe, Matthew T.¹  Ahmad, Tariq¹  Libby, Peter²  Borer, Jeffrey S.³  Hiatt, William R.⁴  Bristow, Michael R.⁴  Packer, Milton⁵  Wasserman, Scott M.⁶  Braunstein, Ned⁷  Pitt, Bertram⁸  DeMets, David L.⁹  Cooper-Arnold, Katharine¹⁰  Armstrong, Paul W.¹¹  Berkowitz, Scott D.¹²  Scott, Rob⁵  Prats, Jayne¹³  Galis, Zorina S.¹⁰  Stockbridge, Norman¹⁴  Peterson, Eric D.¹  Califf, Robert M.¹ 

[1] Duke Clin Res Inst, Durham, NC 27705 USA

[2] Harvard Univ, Brigham & Womens Hosp, Sch Med, Boston, MA 02115 USA

[3] Suny Downstate Med Ctr, Brooklyn, NY 11203 USA

[4] Univ Colorado, Sch Med, Aurora, CO USA

[5] Univ Texas SW Med Ctr Dallas, Dept Clin Neurosci, Dallas, TX 75390 USA

[6] Amgen Inc, Thousand Oaks, CA 91320 USA

[7] Regeneron Pharmaceut Inc, Tarrytown, NY 10591 USA

[8] Univ Michigan, Sch Med, Ann Arbor, MI USA

[9] Univ Wisconsin, Sch Med & Publ Hlth, Madison, WI USA

[10] NHLBI, NIH, Bethesda, MD 20892 USA

[11] Univ Alberta, Canadian VIGOUR Ctr, Edmonton, AB, Canada

[12] Bayer HealthCare Pharmaceut, Whippany, NJ USA

[13] Medicines Co, Parsippany, NJ USA

[14] US FDA, Div Cardiovasc & Renal Prod, Ctr Drug Evaluat & Res, Silver Spring, MD USA

关键词: biomarkers;    cardiovascular;    agents;    clinical trials;    drug costs;    pharmacological;    policy;   

DOI  :  10.1016/j.jacc.2015.03.016

来源: Elsevier

【 摘 要 】

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 end-points. 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. (C) 2015 by the American College of Cardiology Foundation.

【 授权许可】

Free