title: Cardiovascular drug development: is it dead or just hibernating?
abstract: 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.
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina. Electronic address: christopher.fordyce@duke.edu.
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Fordyce
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Matthew T
authors.initials: MT
authors.lastname: Roe
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Tariq
authors.initials: T
authors.lastname: Ahmad
authors.affiliation: Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Peter
authors.initials: P
authors.lastname: Libby
authors.affiliation: State University of New York Downstate Medical Center, Brooklyn, New York.
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Borer
authors.affiliation: University of Colorado School of Medicine, Aurora, Colorado.
authors.forename: William R
authors.initials: WR
authors.lastname: Hiatt
authors.affiliation: University of Colorado School of Medicine, Aurora, Colorado.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Bristow
authors.affiliation: Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas.
authors.forename: Milton
authors.initials: M
authors.lastname: Packer
authors.affiliation: Amgen, Inc., Thousand Oaks, California.
authors.forename: Scott M
authors.initials: SM
authors.lastname: Wasserman
authors.affiliation: Regeneron Pharmaceuticals, Tarrytown, New York.
authors.forename: Ned
authors.initials: N
authors.lastname: Braunstein
authors.affiliation: University of Michigan School of Medicine, Ann Arbor, Michigan.
authors.forename: Bertram
authors.initials: B
authors.lastname: Pitt
authors.affiliation: University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
authors.forename: David L
authors.initials: DL
authors.lastname: DeMets
authors.affiliation: National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Katharine
authors.initials: K
authors.lastname: Cooper-Arnold
authors.affiliation: Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Paul W
authors.initials: PW
authors.lastname: Armstrong
authors.affiliation: Bayer HealthCare Pharmaceuticals, Whippany, New Jersey.
authors.forename: Scott D
authors.initials: SD
authors.lastname: Berkowitz
authors.affiliation: Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas.
authors.forename: Rob
authors.initials: R
authors.lastname: Scott
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Jayne
authors.initials: J
authors.lastname: Prats
authors.affiliation: National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Zorina S
authors.initials: ZS
authors.lastname: Galis
authors.affiliation: Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Norman
authors.initials: N
authors.lastname: Stockbridge
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D035843:Biomedical Research / Q000191:economics; D002317:Cardiovascular Agents / Q000494:pharmacology*; D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence; D003226:Congresses as Topic; D017277:Drug Approval; D055808:Drug Discovery; D004345:Drug Industry; D035082:Federal Government; D033161:Government Regulation; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D002317:Cardiovascular Agents
keywords: biomarkers; cardiovascular agents; clinical trials; drug costs; pharmacological; policy