Cardiovascular drug development: is it dead or just hibernating?
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.
Duke Scholars
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- United States Food and Drug Administration
- United States
- Humans
- Government Regulation
- Federal Government
- Drug Industry
- Drug Discovery
- Drug Approval
- Congresses as Topic
- Clinical Trials as Topic
Citation
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- United States Food and Drug Administration
- United States
- Humans
- Government Regulation
- Federal Government
- Drug Industry
- Drug Discovery
- Drug Approval
- Congresses as Topic
- Clinical Trials as Topic