Exploring the pragmatic-explanatory spectrum across cardiovascular clinical trials.

ABSTRACT

Clinical trials are a cornerstone of modern medicine and form the backbone of evidence that is used to create evidence-based guidelines. Contemporary clinical trials have tended to be quite explanatory, assessing an intervention in ideal conditions with highlyprotocolized interventions, strict inclusion/exclusion criteria, high resource utilization and with frequent (and often specialized) follow-up. In conjunction with decreased event-rates due to the improvement of cardiovascular care, this has resulted in increasingly complex, large, clinical trials that are associated with exponentially increasing costs. This has led to a strong push for streamlined trials that more truly represent "real world" settings and conduct. Such pragmatic trials emphasize "real world" conduct, including broader inclusion criteria that lead to more typical and less carefully selected patient populations, and more realistic trial setting and execution elements. We explore the spectrum of pragmatism across cardiovascular clinical trials, highlighting novel innovations and trends over the past decade.