Duke Office of Clinical Research, Duke University School of Medicine and Duke Clinical Translational Science Institute, Duke University, Durham, NC, USA.
Association of Clinical Research Professionals, Alexandria, VA, USA.
Clin Trials. 2023 Oct;20(5):457-462. doi: 10.1177/17407745231177885. Epub 2023 Jun 2.
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.
临床和转化研究企业被许多人认为是“证据产生系统”。尽管已经有几次呼吁对这一企业进行改革，以更有效地将生物医学科学的成果带给患者和社会，但临床研究人员队伍中存在着许多普遍存在的问题。也许最明显的迹象是，有能力的员工的供应和需求之间差距不断扩大。造成这种情况的原因是一系列复杂问题的完美结合。目前，这个问题已经到了危机点，远远超出了人员配备问题的范畴，最终危及药物和设备开发的“引擎”。鉴于即使是“按部就班”也受到威胁，目前劳动力的危险状况使得提出的企业解决方案可能难以实现。事实上，如何彻底改革临床研究企业的高瞻远瞩的讨论与清醒认识之间存在明显脱节，即任何此类愿景的实施都取决于处于困境中的劳动力。在本文中，我们对劳动力问题进行了简要的法医分析，并初步指出了解决方案可能存在的地方。
