Cardiovascular Drug Development
Open accessAbstract
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.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The output of the drug discovery pipeline has significantly declined in recent decades primarily due to the lack of appropriate cardiac pre-clinical models.
“Despite the urgent need to develop new drugs to treat CVDs, the output of the drug discovery pipeline has significantly declined in recent decades (Fordyce et al., 2015) primarily due to the lack of appropriate cardiac pre-clinical models (Kreutzer et al., 2022).”
From A human engineered mini-heart platform for mimicking ventricular pump function (2025) · cites this paper as Fordyce et al., 2015
The citation lists haven’t been fetched yet
References 97 · Cited by 202
- Authors
- Fordyce, C. B., Roe, M. T., Ahmad, T., Libby, P., Borer, J. S., Hiatt, W. R., Bristow, M. R., Packer, M., Wasserman, S. M., Braunstein, N., Pitt, B., DeMets, D. L., Cooper-Arnold, K., Armstrong, P. W., Berkowitz, S. D., Scott, R., Prats, J., Galis, Z. S., Stockbridge, N., Peterson, E. D., & Califf, R. M.
- Affiliations
- Duke University (US)
- Brigham and Women's Hospital (US)
- SUNY Downstate Health Sciences University (US)
- University of Colorado Anschutz (US)
- The University of Texas Southwestern Medical Center (US)
- Amgen (United States) (US)
- Regeneron (United States) (US)
- University of Michigan (US)
- University of Wisconsin–Madison (US)
- University of Alberta (CA)
- Bayer (United States) (US)
- Medicines Company (United States) (US)
- National Institutes of Health (US)
- United States Food and Drug Administration (US)
- Corresponding author
- Fordyce, Christopher B.
- ORCID
- Fordyce, Christopher B.
- Roe, Matthew T.
- Ahmad, Tariq
- Libby, Peter
- Borer, Jeffrey S.
- Hiatt, William R.
- Bristow, Michael R.
- Packer, Milton
- Wasserman, Scott M.
- Braunstein, Ned
- Pitt, Bertram
- DeMets, David L.
- Armstrong, Paul W.
- Berkowitz, Scott D.
- Prats, Jayne
- Galis, Zorina S.
- Stockbridge, Norman
- Peterson, Eric D.
- Califf, Robert M.
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2015-04
- Volume
- 65
- Issue
- 15
- Pages
- 1567-1582
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W216869754
- Cited by
- 202
- References
- 97
- Citations by year
- 2026: 10 · 2025: 11 · 2024: 18 · 2023: 22 · 2022: 19 · 2021: 25 · 2020: 17 · 2019: 15 · 2018: 17 · 2017: 16 · 2016: 24 · 2015: 8
- FWCI
- 7.38
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Celgene
- Thoratec Corporation
- Regeneron Pharmaceuticals
- Kowa Company
- JenaValve
- Daiichi-Sankyo
- Esperion Therapeutics
- Janssen Pharmaceuticals
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- cardiovascular drug development, cardiovascular outcome trials, drug development investment, cardiovascular endpoints, regulatory review, risk-benefit assessment, pharmaceutical industry, stakeholder consensus, cardiovascular disease
- MeSH terms
- Cardiovascular Agents, Clinical Trials as Topic, Congresses as Topic, Drug Industry, Humans, United States, United States Food and Drug Administration, Drug Approval, Government Regulation, Federal Government, Biomedical Research, Drug Discovery
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
