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.
Duke Scholars
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- United States
- Public-Private Sector Partnerships
- Intersectoral Collaboration
- Humans
- Heart Failure
- Clinical Trials as Topic
- Cardiovascular System & Hematology
- 3201 Cardiovascular medicine and haematology
- 1117 Public Health and Health Services
- 1102 Cardiorespiratory Medicine and Haematology
Citation
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- United States
- Public-Private Sector Partnerships
- Intersectoral Collaboration
- Humans
- Heart Failure
- Clinical Trials as Topic
- Cardiovascular System & Hematology
- 3201 Cardiovascular medicine and haematology
- 1117 Public Health and Health Services
- 1102 Cardiorespiratory Medicine and Haematology