Cardiovascular and Metabolic disease is a major burden worldwide. It has been estimated that deaths due to heart disease will increase by 50% in developed countries and by 100% in low and middle income countries by 2020. However, there has been a decline in all phases of cardiovascular drug development in the past decade. This can be attributed to several factors: increased regulatory demands for more and more data; patient recruitment; complexity of protocols; and studies are long and costly – especially if the results do not result in any new treatments or have a negative impact on the subjects. It is clear, therefore, a new way of conducting trials in a cost-effective and more streamlined manner needs to be found.
- Large number of subjects needed and target population is decreasing due stringent inclusion / exclusion requirements
- Trials are complex and costly – it can take 10 years and an investment of $4 Billion to bring one new novel drug to market
- Regulatory agencies are demanding more and more data, with an emphasis on clinical outcome, which increases the complexity of the protocols
- Global scientific networks and peer-to-peer leadership model greatly increase recruitment of the right subjects at the right locations
- Operational excellence ensures faster start-up and trial management
- Deep in-house Cardiovascular expertise and access to academic institutions that aid in protocol development
- Comprehensive understanding of the regulatory environment