TRENDS AND CONSIDERATIONS IN GLOBAL CARDIOVASCULAR DRUG DEVELOPMENT
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
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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