Cardiovascular drug development: is it dead or just hibernating?

J Am Coll Cardiol. 2015 Apr 21;65(15):1567-82. doi: 10.1016/j.jacc.2015.03.016.


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.

Keywords: biomarkers; cardiovascular agents; clinical trials; drug costs; pharmacological; policy.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Biomedical Research / economics
  • Cardiovascular Agents / pharmacology*
  • Clinical Trials as Topic / economics
  • Clinical Trials as Topic / legislation & jurisprudence
  • Congresses as Topic
  • Drug Approval
  • Drug Discovery*
  • Drug Industry
  • Federal Government
  • Government Regulation
  • Humans
  • United States
  • United States Food and Drug Administration


  • Cardiovascular Agents