Key result
High cardiovascular outcome trial costs drive stagnating investment in cardiovascular drug development.
Why the study?
Investment in cardiovascular drug development has stagnated over the past 2 decades due to multifactorial reasons including high costs of outcome trials in the current regulatory environment.
Provides a consensus-based overview of the challenges in cardiovascular drug development and offers potential solutions to stimulate investment and innovation.
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.
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Fordyce et al. (2015) conducted a review in Cardiovascular disease. A 2014 think tank meeting of stakeholders identified the high cost of cardiovascular outcome trials as a primary driver of stagnating investment in cardiovascular drug development.
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