Developing a Robust Clinical Trials Workforce

By Ann Bonham, Robert Califf, Elaine Gallin, Michael Lauer
April 27, 2012 | Discussion Paper

The gap between the growing demand for evidence to inform practice and our current state of knowledge calls for serious consideration about the best approach to developing a workforce capable of meeting those demands. As referenced in the discussion paper The Clinical Trials Enterprise in the United States: A Call for Disruptive Innovation (Califf et al., 2012), the clinical trials enterprise (CTE) is falling behind in the need for evidence, especially in the United States. We envision a need for a clinical research workforce organized in several dimensions that reflect the broad missions of the CTE, the specific disciplines involved, and the level of desirable expertise. The latter could range from broad participation in the CTE to expert participation, and to conceptualization and research on the methods employed by the CTE.

In addition, this workforce must be broadened tremendously to meet the goal implicit in the creation of a true learning health system: the integration 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.

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