Improving Heart Failure Therapeutics Development in the United States: The Heart Failure Collaboratory.
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.
O'Connor, CM; Psotka, MA; Fiuzat, M; Lindenfeld, J; Abraham, WT; Bristow, MR; Canos, D; Harrington, RA; Hillebrenner, M; Jessup, M; Malik, FI; Solomon, SD; Stockbridge, N; Tcheng, JE; Unger, EF; Whellan, DJ; Zuckerman, B; Califf, RM
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