Cardiovascular drug development: is it dead or just hibernating?

Area of Science:

• Cardiovascular Medicine
• Drug Development
• Regulatory Science

Background:

• Global cardiovascular disease burden remains high.
• Investment in cardiovascular drug development has stagnated for two decades.
• Underinvestment is notable compared to other therapeutic areas.

Purpose of the Study:

• To identify reasons for the stagnation in cardiovascular drug development.
• To understand challenges within the current regulatory environment for cardiovascular outcome trials.
• To propose solutions for improving cardiovascular drug development.

Main Methods:

• Summary of proceedings from a July 2014 think tank meeting.
• Involved stakeholders from academia, industry, regulatory bodies, and government agencies.
• Focused on identifying adverse trends and underlying issues.

Main Results:

• High cost of cardiovascular outcome trials is a primary concern.
• Current regulatory demands for risk/benefit assessment using clinical endpoints increase trial costs.
• Identified multifactorial reasons for investment stagnation.

Conclusions:

• A need exists for consensus on improving the cardiovascular drug development environment.
• Addressing the high cost and regulatory demands of trials is crucial.
• Potential solutions were discussed to revitalize investment and research.