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

Christopher M O'Connor1, Mitchell A Psotka1, Mona Fiuzat2

  • 1Inova Heart & Vascular Institute, Falls Church, Virginia.

Journal of the American College of Cardiology
|February 2, 2018
PubMed

Insights

Heart failure clinical trials face challenges like cost and low participation. Stakeholders convened to discuss strategies for improving trial efficiency and accelerating new therapy development.

Area of Science:

  • Cardiovascular Medicine
  • Clinical Trial Management

Background:

  • Clinical trials for heart failure are increasingly complex and costly.
  • Challenges include regulatory hurdles, stakeholder demands, and declining patient and investigator engagement.

Purpose of the Study:

  • To summarize discussions among diverse stakeholders on improving heart failure clinical trials.
  • To identify current challenges and actionable opportunities for enhancing trial efficiency and therapeutic development.

Main Methods:

  • Convening of key stakeholders including patients, investigators, industry, payers, and government representatives (FDA, NIH, CMS) in March 2017.
  • Summarizing discussions, outlining challenges, and formulating recommendations.

Main Results:

  • Identified significant strains on the current heart failure clinical trial environment.
  • Outlined actionable opportunities and targeted recommendations for improvement.

Conclusions:

  • Formation of an organized Heart Failure Collaboratory is recommended.
  • Improving clinical trial efficiency is crucial for speeding the development of effective heart failure therapies.

Keywords:
Food and Drug Administrationcardiovascularclinical trialenrollmentheart failurerecruitment

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