By Karen Hill is the Senior Vice President, Global Project Management, Cardiometabolic for Worldwide Clinical Trials
The value of cardiovascular outcome trials (CVOTs) in drug discovery is increasingly recognized by industry stakeholders. These large-scale studies — and the vast databases they create — not only give us an understanding of a specific intervention and disease, but they also answer other more general questions relating to a patient population.
Guidance from the U.S. Food and Drug Administration currently mandates all type 2 diabetes products perform a CVOT. However, regulators and payers are increasingly demanding such trials for other disease and indications such as chronic kidney disease, dyslipidemia, thrombosis and anemia. Consequently, the industry will continue to see an uptick in these initiatives.
In synch with the size of the opportunity, however, the complexities and resource requirements of these undertakings are also significant. CVOTs typically encompass thousands of patients, hundreds of global sites, huge amounts of data and notable staff requirements. If not thoughtfully planned and strategically managed, costs can quickly spiral out of control.
Emerging best practices point to three factors that can have a dramatic bottom-line impact on CVOTs. In one case, for example, it meant the difference between a budget of $100 million and $50 million in clinical research organization (CRO) direct fees.