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

Published

Journal Article (Review)

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.

Full Text

Duke Authors

Cited Authors

  • 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

Published Date

  • January 30, 2018

Published In

Volume / Issue

  • 71 / 4

Start / End Page

  • 443 - 453

PubMed ID

  • 29389362

Pubmed Central ID

  • 29389362

Electronic International Standard Serial Number (EISSN)

  • 1558-3597

Digital Object Identifier (DOI)

  • 10.1016/j.jacc.2017.11.048

Language

  • eng

Conference Location

  • United States