Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Oct;20(5):457-462.
doi: 10.1177/17407745231177885. Epub 2023 Jun 2.

Now is the time to fix the clinical research workforce crisis

Affiliations

Now is the time to fix the clinical research workforce crisis

Stephanie A Freel et al. Clin Trials. 2023 Oct.

Abstract

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.

Keywords: Clinical research; clinical research coordinator; clinical research professional; clinical research workforce; drug development; recruitment; research nursing; retention; translational research; workforce development.

PubMed Disclaimer

Conflict of interest statement

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

References

    1. Califf RM. Now is the time to fix the evidence generation system. Clin Trials 2023; 20(1): 3–12. - PubMed
    1. Clinical Trials Administrator Archives. Shortage of nurses, docs hurts CR staff hiring, retention rates, https://www.reliasmedia.com/articles/111576-shortage-of-nurses-docs-hurt... (2009, accessed 27 March 2023).
    1. Miseta E. Clinical staff shortage: “growing plague” for pharma & CROs. Clinical Leader, https://www.clinicalleader.com/doc/clinical-staff-shortage-growing-plagu... (2016, accessed 27 March 2023).
    1. Actalent. The staffing crisis in clinical trials and the drive for permanent staff, https://www.actalentservices.com/en-gb/insights/articles/the-staffing-cr... (2018, accessed 27 March 2023).
    1. Stabile S, Cenna R, Sinno V, et al.. Clinical trial units and clinical research coordinators: a system facing crisis? About Open (Clin Res) 2023; 10: 1–3.

Publication types

LinkOut - more resources