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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Disclaimer: The views expressed in this paper are those of the authors and not necessarily of the authors’ organizations, the National Academy of Medicine (NAM), or the National Academies of Sciences, Engineering, and Medicine (the National Academies). The paper is intended to help inform and stimulate discussion. It is not a report of the NAM or the National Academies. Copyright by the National Academy of Sciences. All rights reserved.