Improving Heart Failure Therapeutics Development in the United States The Heart Failure Collaboratory

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:71

Review

O'Connor, Christopher M.¹  Psotka, Mitchell A.¹  Fiuzat, Mona²  Lindenfeld, Joann³  Abraham, William T.^4,5,6,7  Bristow, Michael R.^8,9  Canos, Daniel¹⁰  Harrington, Robert A.¹¹  Hillebrenner, Matt¹²  Jessup, Mariell¹³  Malik, Fady I.¹⁴  Solomon, Scott D.¹⁵  Stockbridge, Norman¹²  Tcheng, James E.¹⁶  Unger, Ellis F.¹²  Whellan, David J.¹⁷  Zuckerman, Bram¹²  Califf, Robert M.^11,16,18,19 

[1] Inova Heart & Vasc Inst, 300 Gallows Rd, Falls Church, VA 22042 USA

[2] Duke Univ, Sch Med, Dept Med, Durham, NC 27706 USA

[3] Vanderbilt Heart & Vasc Inst, Heart Failure & Transplantat Sect, Nashville, TN USA

[4] Ohio State Univ, Dept Med, Div Cardiovasc Med, Columbus, OH 43210 USA

[5] Ohio State Univ, Dept Physiol, Div Cardiovasc Med, Columbus, OH 43210 USA

[6] Ohio State Univ, Dept Cell Biol, Div Cardiovasc Med, Columbus, OH 43210 USA

[7] Ohio State Univ, Davis Heart & Lung Res Inst, Columbus, OH 43210 USA

[8] Univ Colorado, Cardiovasc Inst, Boulder, CO 80309 USA

[9] Univ Colorado, Cardiovasc Inst, Aurora, CO USA

[10] Ctr Med & Medicaid Serv, Baltimore, MD USA

[11] Stanford Univ, Dept Med, Palo Alto, CA 94304 USA

[12] US FDA, Silver Spring, MD USA

[13] Leducq Fdn, Boston, MA USA

[14] Cytokinetics Inc, San Francisco, CA USA

[15] Brigham & Womens Hosp, Cardiovasc Div, 75 Francis St, Boston, MA 02115 USA

[16] Duke Univ, Sch Med, Dept Med, Div Cardiol, Durham, NC 27706 USA

[17] Thomas Jefferson Univ, Dept Med, Philadelphia, PA 19107 USA

[18] Duke Clin Res Inst, Durham, NC USA

[19] Verily Life Sci, San Francisco, CA USA

关键词: cardiovascular;    clinical trial;    enrollment;    Food and Drug Administration;    heart failure;    recruitment;   

DOI  :  10.1016/j.jacc.2017.11.048

来源: Elsevier

【 摘 要 】

The current heart failure clinical trial environment is strained by increasing complexity and cost, regulatory requirements, competing demands on stakeholders, implementation challenges, and decreasing patient and investigator participation. To begin the process of developing potentially effective strategies and tactics, stakeholders including patients; investigators; academic leaders; pharmaceutical and device industry representatives; society representatives; third-party payers; and government representatives from the U.S. Food and Drug Administration, National Institutes of Health, and Centers for Medicare and Medicaid Services convened in March of 2017. This paper summarizes the discussions, outlines current challenges and actionable opportunities, and makes targeted recommendations to achieve the goals of improving efficiency in clinical trials and speeding the development of effective heart failure therapies, including the formation of an organized Heart Failure Collaboratory. (c) 2018 Published by Elsevier on behalf of the American College of Cardiology Foundation.

【 授权许可】

Free