National Academy of Medicine

The Clinical Trials Enterprise in the United States: A Call for Disruptive Innovation

By Robert M. Califf, Gary L. Filerman, Richard K. Murray, Michael Rosenblatt
April 20, 2012 | Discussion Paper

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.



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