TRENDS AND CONSIDERATIONS IN GLOBAL CARDIOVASCULAR DRUG DEVELOPMENT Carol Duffy, DO, FACC; Judy Reddinger; Sandra Schefler; Andrea Schiefer, PhD; Clareece West Cardiovascular diseases are the number one cause of death worldwide, and today’s rich biopharmaceutical pipeline holds more than 350 experimental cardiovascular agents. Multinational trials are developing these new therapies across a divergent research landscape, from the mature markets of North American and the European Union to emerging markets in Latin America, Eastern Europe and the Asia Pacific. To conduct successful multinational studies, sponsors must ensure consistency across varying regulatory requirements and standards of care as they manage trial operations country-by-country. In this paper, Clinipace discusses trends in global cardiovascular research and shares its views on key planning and operational considerations regarding regulation, patient and investigator recruitment, technology platforms and clinical supply management. Introduction The impact of cardiovascular disease (CVD) on global health and escalating healthcare costs will increase dramatically in the coming decade. The world’s aging population, together with the alarming rise in type 2 diabetes and obesity, will increase morbidity and mortality due to cardiovascular diseases in both developed and emerging nations. The leading cause of death worldwide, cardiovascular diseases accounted for 30 percent of all global deaths in 2008, with an estimated 7.3 million deaths due to coronary heart disease and 6.2 million due 1 to stroke. In addition, it is now well documented that peripheral arterial disease (PAD) is a marker of systemic atherosclerosis. In addition, the ACC/AHA Task Force on Performance Measures in 2011 provided an alarming assessment of PAD’s impact. Not only do PAD patients experience an overall decline in well-being, but PAD is