Drug Development

Now is the time to fix the clinical research workforce crisis

Freel SA, Snyder DC, Bastarache K, Jones CT, Marchant MB, Rowley LA, Sonstein SA, Lipworth KM, Landis SP. Now is the time to fix the clinical research workforce crisis. Clinical Trials. 2023;0(0). doi:10.1177/17407745231177885

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.

Investigator selection for multicenter clinical trials: Remembering our ethical obligations to clinical trial volunteers

Arquiza M, Veresh B. Investigator selection for multicenter clinical trials: Remembering our ethical obligations to clinical trial volunteers. Clinical Researcher. 2015 Jun; 29(3): 24-27. https://acrpnet.org/crjune2015/ (PDF) 

Core Competencies for pharmaceutical physicians and drug development scientists

**NEW** From Frontiers in Pharmacology: Core Competencies for pharmaceutical physicians and drug development scientists:

  pharmaceutical-medicine-core-competencies.pdf