gration of research and continuous learning into practice. However, the more traditional arenas of mechanistic research and efficacy trials call for specialized workforces that until now have all too often depended on ad hoc, “on-the-job” learning, as opposed to the prospective training and education that defines a mature discipline. Finally, the new field of community engagement requires special skills that blend traditional clinical trials knowledge with social and organizational constructs.
The challenge is considerable, because most roles in clinical research at their core involve human experimentation and require specific expertise in a clinical or scientific discipline. Moreover, this expertise must be augmented by focused training in the standards and principles that undergird the conduct of particular types of clinical trials, which range from small, intensive mechanistic studies to very large, community-based interventions.
A Salutary Example: The Occluded Artery Trial (OAT)
One example of the need for broadening the discipline to include medical practitioners is the recent OAT Trial, a cardiology study funded by the National Institutes of Health (NIH). In the 1990s, cardiologists sought to understand how best to manage patients who survived the first few days of ST-segment-elevation acute myocardial infarction (STEMI), but with persistent total occlusions of their infarct-related artery. The enormous benefits of rapid reperfusion in the acute phase of STEMI had already been established in well-controlled clinical trials. Although the detection of an occluded artery several days after the onset of the STEMI would come too late for treatment to be effective in salvaging damaged heart muscle, cardiologists wondered whether there might still be benefit in deploying stents to open up the occluded arteries; the newly opened arteries might supply blood to “watershed” areas at the edge of the infarct zone, thereby reducing the risk of life-threatening arrhythmias and other major events. Further, experimental evidence suggested that the infarction might heal more effectively with perfusion.
Some investigators analyzed observational cohorts and found that patients who were discharged with patent arteries did indeed fare better. The “open artery hypothesis” was alive and supported by observational evidence, so much so that for many cardiologists it became standard practice to ensure that their STEMI patients went home with an open artery.
However, some academic cardiologists questioned whether routine post-STEMI stenting of persistently occluded arteries was of clinical value: Did this practice actually improve clinical outcomes? With support from the National Heart, Lung, and Blood Institute (NHLBI), they organized OAT, a multicenter clinical trial in which patients would be randomly