New agents, new trials, new solutions

Dramatic advances in biological understanding, coupled with improved knowledge about appropriate clinical trial design and transformation of the healthcare system into a business paradigm, have created a dynamic situation for evaluating new therapies for patients with acute ischemic syndromes. Multiple avenues for alteration of the basic components of acute ischemia are possible, ranging from manipulation of the coagulation system to stabilization of the vulnerable atherosclerotic plaque. The trials required to demonstrate a role for such therapies must involve large numbers of patients and must measure clinical outcomes rather than pathophysiological surrogates. Given the increasing restriction of the rate of growth of funding for medical care, it is more important than ever that new therapies demonstrate cost effectiveness and practical feasibility. While current clinical trials focus on thrombolytic agents, antithrombin agents, and platelet glycoprotein IIb/IIIa inhibitors, future trials will address multiple other biological targets. The clinical community bears the responsibility of developing methods to rapidly assess these potential advances.

Duke Scholars

Author Robert M. Califf Medicine, Cardiology