Over the past decade, the symbiotic relationship between the clinical trials enterprise (CTE) and the health care delivery system has been subject to increasing amounts of stress. During this period, the CTE has primarily focused on process improvement, seeking to create and maintain procedures and data systems that can satisfy a regulatory environment concerned with specific research procedures. These efforts have driven up the cost of research and left the CTE increasingly out of sync with the health care delivery system.
At the same time, there have been many significant changes in the health care delivery system, changes largely concerned with organization, quality improvement, operational efficiency, and error reduction and patient safety. Despite significant rhetoric (particularly in the United States) about “learning health systems” (Institute of Medicine [IOM], 2007), the CTE and the health care delivery system have continued to diverge. This situation is undesirable both because research done within such a partitioned, parallel system may not be broadly generalizable and because the cost of maintaining parallel systems limits our ability to address critical gaps in knowledge.