Prashant AP
Despite major advancement in drug development heart disease and stroke remain major public concern due to primary cause of death. In developing nations, more than 20-25 million peoples are projected to die due to cardiovascular disease by 2020. The burden of cardiovascular disease clearly remains both a major public health concern and growing global challenge.
The number of cardiovascular drugs in the research pipeline has declined across all phases of development in the last 20 years even as cardiovascular disease has become the No. 1 cause of death worldwide. The reason for this trend is multifactorial but primary reason is cost of conducting cardiovascular outcome trials in the current regulatory environment that demands a direct assessment of risks and benefits. It is difficult to prove treatment benefits in cardiovascular space compared with other therapeutic areas like Neuroscience and oncology. The Global challenges to bring new cardiovascular drugs in to the market go beyond scientific breakthroughs and innovation. The key challenges are:
• Rising cost
• Regulatory uncertainty
• Decline in new drug targets
• Late-stage failures
• Complexity in clinical trial design
End point studies having surrogate markers are the pivotal for the cardiovascular drug development. Innovative technology, web based conduct and global participation is needed to overcome global challenges.
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