Cardiovascular drug development: Is it dead or just hibernating?

Christopher B. Fordyce, Matthew T. Roe, Tariq Ahmad, Peter Libby, Jeffrey S. Borer, William R. Hiatt, Michael R. Bristow, Milton Packer, Scott M. Wasserman, Ned Braunstein, Bertram Pitt, David L. Demets, Katharine Cooper-Arnold, Paul W. Armstrong, Scott D. Berkowitz, Rob Scott, Jayne Prats, Zorina S. Galis, Norman Stockbridge, Eric D. PetersonRobert M. Califf

Research output: Contribution to journalReview articlepeer-review

115 Scopus citations


Despite the global burden of cardiovascular disease, investment in cardiovascular drug development has stagnated over the past 2 decades, with relative underinvestment compared with other therapeutic areas. The reasons for this trend are multifactorial, but of primary concern is the high cost of conducting cardiovascular outcome trials in the current regulatory environment that demands a direct assessment of risks and benefits, using clinically-evident cardiovascular endpoints. To work toward consensus on improving the environment for cardiovascular drug development, stakeholders from academia, industry, regulatory bodies, and government agencies convened for a think tank meeting in July 2014 in Washington, DC. This paper summarizes the proceedings of the meeting and aims to delineate the current adverse trends in cardiovascular drug development, understand the key issues that underlie these trends within the context of a recognized need for a rigorous regulatory review process, and provide potential solutions to the problems identified.

Original languageEnglish (US)
Pages (from-to)1567-1582
Number of pages16
JournalJournal of the American College of Cardiology
Issue number15
StatePublished - Apr 21 2015


  • biomarkers
  • cardiovascular agents
  • clinical trials
  • drug costs
  • pharmacological
  • policy

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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