Autor: |
Freel SA; Duke Office of Clinical Research, Duke University School of Medicine and Duke Clinical Translational Science Institute, Duke University, Durham, NC, USA., Snyder DC; Duke Office of Clinical Research, Duke University School of Medicine and Duke Clinical Translational Science Institute, Duke University, Durham, NC, USA., Bastarache K; Association of Clinical Research Professionals, Alexandria, VA, USA., Jones CT; Center for Clinical and Translational Science, College of Nursing, The Ohio State University, Columbus, OH, USA., Marchant MB; The University of Alabama at Birmingham, Birmingham, AL, USA., Rowley LA; North Carolina Biotechnology Center, Research Triangle Park, NC, USA., Sonstein SA; Multi-Regional Clinical Trials Center of Brigham and Women's and Harvard, Cambridge MA, USA., Lipworth KM; Association of Clinical Research Professionals, Alexandria, VA, USA., Landis SP; Association of Clinical Research Professionals, Alexandria, VA, USA. |
Abstrakt: |
The clinical and translational research enterprise is recognized by many as the "evidence generation system." While there have been several calls to revolutionize this enterprise to more effectively deliver the fruits of biomedical science to patients and society, significant issues across the clinical research workforce are pervasive. Perhaps the most visible sign is the widening gap between supply and demand for competent staff. Underpinning this, is a perfect storm of complex issues. Now reaching crisis point, this problem is far bigger than a staffing issue and ultimately jeopardizes the "engine" of drug and device development. With the current perilous state of the workforce, proposed enterprise fixes are likely to languish far out of reach, given that even "business as usual" is under threat. In fact, a glaring disconnect is evident between the visionary discourse on how to revolutionize the clinical research enterprise and the sober recognition that operationalization of any such vision rests on the shoulders of a workforce that's in dire straits. In this article, we provide a brief forensic analysis of the workforce problem and an initial indication of where solutions may lie. |