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

Jobs for clinical research professionals (CRPs) have grown increasingly complex over the past 20+ years. This is due largely to additional administrative burden for investigators, study teams, sponsors, Clinical Research Organizations (CROs), and sites, particularly Academic Medical Centers (AMCs). Furthermore, National Institutes of Health (NIH) has reduced capacity to effectively fund research recognizing this is dependent on the overall congressional budget, which creates greater pressure for clinician scientists to secure external support. It is widely known clinical research will continue to become increasingly more complex for clinician scientists. This manuscript explores adoption of a clinical research competency-based job classification framework from the Joint Task Force for Clinical Trial Competency (JTFCTC) across several AMCs and the role of Human Resources (HR) in facilitating this process. This collaboration focuses on fostering successful projects tied to the business case in order to address equity and improve support for the clinical research enterprise.

Andragogy in Practice: Applying a Theoretical Framework to Team Science Training in Biomedical Research.

This study is the first to apply the theoretical principles of Malcolm Knowles' theory of andragogy to evaluate data collected from learners who participated in team science training workshops in a biomedical research setting. Briefly, andragogy includes six principles: the learner's self-concept, the role of experience, readiness to learn, orientation to learning, the learner's need to know, and intrinsic motivation. Using an embedded study design, the primary focus was on qualitative data, with quantitative data complementing the qualitative findings. The deductive analysis demonstrated that approximately 85% of the qualitative data could be connected to at least one andragogical principle. Participant responses to positive evaluation questions were largely related to two principles: readiness to learn and problem-based learning orientation. Participant responses to negative questions were largely connected to two different principles: the role of experience and self-direction. Inductive analysis found an additional theme: meeting biological needs. Quantitative survey results supported the qualitative findings. The study findings demonstrate that andragogy can serve as a valuable construct to integrate into the development of effective team science training for biomedical researchers.

Development of an undergraduate certificate in clinical and translational science: improving competence of the clinical research workforce.

Introduction: Academic research centers often struggle to recruit and retain a well-trained and diverse clinical and translational science (CTS) workforce. In particular, the clinical research professional (CRP) career pathway is not well known to undergraduate students and other individuals outside of academic medicine despite being a potential career route. To address these workforce challenges, the CRP Task Force at the University of Cincinnati (UC) aims to train a competent and diverse CRP workforce through targeted educational programming in the UC undergraduate population. Methods: Using a six-step curriculum development process that included: 1) performing a needs assessment, 2) determining content, 3) writing goals and objectives, 4) selecting the educational strategies, 5) implementing the curriculum, and 6) evaluating the curriculum, we designed an undergraduate certificate program in CTS. Results: The needs assessment included both internal and external data gathering to inform curriculum development and program decisions. Content was determined using the Core Competency Framework for the Clinical Research Professional Version 3.1., and program learning outcomes were written with both the competency framework and local workforce needs in mind. Educational strategies were selected based on optimization of available resources and local expertise with an emphasis on interactive didactics complemented by experiential learning. Implementation is underway and evaluation will follow once students begin enrolling. Discussion: By educating an undergraduate student population about CTS methods and career opportunities, we anticipate increased numbers of well-qualified, diverse applicants who pursue CRP careers locally and regionally.

Kruppel-like factor 5 is required for formation and differentiation of the bladder urothelium.

Kruppel-like transcription factor 5 (Klf5) was detected in the developing and mature murine bladder urothelium. Herein we report a critical role of KLF5 in the formation and terminal differentiation of the urothelium. The Shh(GfpCre) transgene was used to delete the Klf5(floxed) alleles from bladder epithelial cells causing prenatal hydronephrosis, hydroureter, and vesicoureteric reflux. The bladder urothelium failed to stratify and did not express terminal differentiation markers characteristic of basal, intermediate, and umbrella cells including keratins 20, 14, and 5, and the uroplakins. The effects of Klf5 deletion were unique to the developing bladder epithelium since maturation of the epithelium comprising the bladder neck and urethra was unaffected by the lack of KLF5. mRNA analysis identified reductions in Pparγ, Grhl3, Elf3, and Ovol1expression in Klf5 deficient fetal bladders supporting their participation in a transcriptional network regulating bladder urothelial differentiation. KLF5 regulated expression of the mGrhl3 promoter in transient transfection assays. The absence of urothelial Klf5 altered epithelial-mesenchymal signaling leading to the formation of an ectopic alpha smooth muscle actin positive layer of cells subjacent to the epithelium and a thinner detrusor muscle that was not attributable to disruption of SHH signaling, a known mediator of detrusor morphogenesis. Deletion of Klf5 from the developing bladder urothelium blocked epithelial cell differentiation, impaired bladder morphogenesis and function causing hydroureter and hydronephrosis at birth.

COVID-19 Vaccine Hesitancy: A Critical Time Period Analysis.

The COVID-19 pandemic has been a devastating, global public health crisis. Public health systems in the United States heavily focused on getting people to adhere to preventive behaviors, and later, to get vaccinated. January through May of 2021 was a critical and volatile time period for COVID-19 cases, deaths, and expanding vaccination programs coinciding with important political and social events which will have a lasting impact on how the public views science, places trust in our government, and views individual rights. Having collected almost 1400 surveys, our goal was to assess vaccine behavior, explore attitudes toward receiving the vaccine, and identify trusted information sources. More than 83% of our survey respondents said they were at least partially vaccinated. Of 246 unvaccinated, 31.3% were somewhat or extremely likely to get vaccinated when available. Their two most common concerns were vaccine effectiveness (41.1%) and safety (40.2%). Significant differences were observed between respondents who were likely to be vaccinated in the future and those who were hesitant on three of five demographic variables. Our data provide unique insight into the history of behavior and motivations related to COVID-19 vaccines-what will be seen as a "wicked problem" for years to come.

Academic medical center clinical research professional workforce: Part 2 - Issues in staff onboarding and professional development.

Background: Defining key barriers to the development of a well-trained clinical research professional (CRP) workforce is an essential first step in identifying solutions for successful CRP onboarding, training, and competency development, which will enhance quality across the clinical and translational research enterprise. This study aimed to summarize barriers and best practices at academic medical centers related to effective CRP onboarding, training, professional development, identify challenges with the assessment of and mentoring for CRP competency growth, and describe opportunities to improve training and professionalization for the CRP career pathway. Materials/Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore the complex issues involved when developing high-quality onboarding and continuing education opportunities for CRPs at academic medical centers. Results: Results suggest there are several barriers to training the CRP workforce, including balancing foundational onboarding with role-based training, managing logistical challenges and institutional contexts, identifying/enlisting institutional champions, assessing competency, and providing high-quality mentorship. Several of these themes are interrelated. Two universal threads present throughout all themes are the need for effective communication and the need to improve professionalization of the CRP career pathway. Conclusion: Few institutions have solved all the issues related to training a competent and adaptable CRP workforce, although some have addressed one or more. We applied a socio-technical lens to illustrate our findings and the need for NCATS-funded academic medical centers to work collaboratively within and across institutions to overcome training barriers and support a vital, well-qualified workforce and present several exemplars from the field to help attain this goal.

Issues for recruitment and retention of clinical research professionals at academic medical centers: Part 1 - collaborative conversations Un-Meeting findings.

Background: Identification of evidence-based factors related to status of the clinical research professional (CRP) workforce at academic medical centers (AMCs) will provide context for National Center for Advancing Translational Science (NCATS) policy considerations and guidance. The objective of this study is to explore barriers and opportunities related to the recruitment and retention of the CRP workforce. Materials and Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore barriers and recommendations for improving AMC CRP recruitment, retention and diversity. Results: While certain institutions have established competency-based frameworks for job descriptions, standardization remains generally lacking across CTSAs. AMCs report substantial increases in unfilled CRP positions leading to operational instability. Data confirmed an urgent need for closing gaps in CRP workforce at AMCs, especially for attracting, training, retaining, and diversifying qualified personnel. Improved collaboration with human resource departments, engagement with principal investigators, and overcoming both organizational and resource challenges were suggested strategies, as well as development of outreach to universities, community colleges, and high schools raising awareness of CRP career pathways. Discussion: Based on input from 130 CRP leaders at 35 CTSAs, four National Institute of General Medical Sciences' Institutional Development Award (IDeA) program sites, along with industry and government representatives, we identified several barriers to successful recruitment and retention of a highly trained and diverse CRP workforce. Results, including securing institutional support, champions, standardizing and adopting proven national models, improving local institutional policies to facilitate CRP hiring and job progression point to potential solutions.