Now is the time to fix the clinical research workforce crisis

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.

Education and training of clinical research professionals and the evolution of the Joint Task Force for Clinical Trial Competency

“…This manuscript summarizes the decade-long evolution and impact of the JTF Framework on the education and professionalization of CRPs, investigators and their study teams, pharmaceutical, and other professionals involved in medicine development and clinical research. Professionalizing the workforce is a strategic goal for the clinical research enterprise as shortages in the workforce threaten operations and clinical trial progress ( Freel et al, 2023 ). The basic content for clinical research professional academic curricula, training curricula, job titles, professional advancement, ePortfolios, professional certification, research, team science competencies for CRPs, competency assessments, and international applications are all influenced by the adoption and application of the JTF Framework ( Association of Clinical Research Professionals, 2018 ; Stonier et al, 2020 ; Ivey, 2021 ; Jones et al, 2021 ; Society of Clinical Research Associates ; Sonstein et al, 2022b ; Glaettli et al, 2022 ; Ibrahim et al, 2022 ; Mendell et al, 2023 ).…”

“…A pharmaceutical physician is a medicine development role that requires a baccalaureate degree, an MD and licensure, or a PharmD, who has an additional diploma education in pharmaceutical medicine ( Silva et al, 2013 ). Advancement pathways for these individuals working at the research site and in the pharmaceutical industry are beginning to be better defined; however, in today’s workforce climate, severe staff shortages threaten to slow clinical research progress ( Freel et al, 2023 ). The professionalization of the clinical research workforce is dependent on the early recognition of the professional roles and their importance and competency standards defining the work, educational pathways, and professional development paths so that the pool of individuals interested in this work are aware of the opportunities in this field.…”

Pilot implementation of a co-mentoring circles program for the clinical research professionals: Evidence for formative evaluation and logic model

“…The increasing number and complexity of clinical trial protocols have generated an unrelenting demand for proficient CRPs, a demand that consistently surpasses available resources. This demand underscores the urgent need to cultivate and sustain a skilled and seasoned CRP workforce that supports the expansive clinical research domain [ 1 ]. Meanwhile, high staff turnover at academic medical centers endangers the sustainability of the CRP workforce.…”

Enhancing the clinical research workforce: a collaborative approach with human resources

“…However, with ill-defined jobs, it is often arduous to garner how many clinical research professionals (CRPs) are hired ( Bocchino et al, 2020 ), thus actual costs of training have likely been underestimated. These CRP jobs are in high demand, with increasingly documented shortages related to a workforce in crisis ( Freel et al, 2023 ).…”