Cardiovascular drug development: is it dead or just hibernating?

Journal Article (Journal Article;Review)

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.

Full Text

Duke Authors

Cited Authors

  • Fordyce, CB; Roe, MT; Ahmad, T; Libby, P; Borer, JS; Hiatt, WR; Bristow, MR; Packer, M; Wasserman, SM; Braunstein, N; Pitt, B; DeMets, DL; Cooper-Arnold, K; Armstrong, PW; Berkowitz, SD; Scott, R; Prats, J; Galis, ZS; Stockbridge, N; Peterson, ED; Califf, RM

Published Date

  • April 21, 2015

Published In

Volume / Issue

  • 65 / 15

Start / End Page

  • 1567 - 1582

PubMed ID

  • 25881939

Electronic International Standard Serial Number (EISSN)

  • 1558-3597

Digital Object Identifier (DOI)

  • 10.1016/j.jacc.2015.03.016


  • eng

Conference Location

  • United States