Nurses in clinical trials: perceptions of impact on the research enterprise

Abstract

Background Clinical Research Nurses practice across a wide spectrum of roles and settings within the global research enterprise. Clinical Research Nurses working with clinical trials face a dual fidelity in their role, balancing integrity of the protocol and quality care for participants. Aims The purpose of this study was to describe Clinical Research Nurses’ experiences in clinical trials, educational preparation, and career pathways, to gain a deeper understanding of clinical research nursing contributions to the clinical research enterprise. Methods An internet-based survey was conducted to collect demographic data and free text responses to four open-ended queries related to the experience of nurses working in clinical trials research, educational preparation, and role pathways. Qualitative content analysis was used to analyze free text responses. The study was guided by the Clinical Research Nursing Domain of Practice and Duffy’s Quality Caring Model of relationship centered professional encounters. Results Forty clinical research nurses responded to the open-ended questions with themes related to dual fidelity to study participants and protocols, relationships and nursing care, interdisciplinary team membership and contributing to science, emerging from the data. Gaps in educational preparation and professional pathways were identified. Conclusion This study provides insights to unique clinical research nurse practice contributions in the clinical trial research enterprise within a context of Duffy’s Quality Caring Model.

Exploration of Lived Experiences and Measurement of Burnout Among US Clinical Research Nurses

“…On the basis of previous research that centered on the CRN specialty-specific challenges related to delegative role, preestablished areas of interest, described as domains of change, were measured via open-ended survey responses. Jones et al 16 emphasized the unique competency of CRNs related to clinical trial participant management, which encompasses research and clinically based care components to ensure alignment among investigational and standard treatments. Workload and perceived level of stress were noted as trending issues among CRNs in research conducted by Shiely et al, 17 noting the complexity and multifaceted nature of clinical trials as priority areas of focus for assigning workload.…”

“…26 This shift in CRN identity from hospital setting to remote setting requires additional efforts to promote belonging and professional feelings of mattering to the organization. 16 The culture of belonging and mattering not only is a means of reducing stress and burnout among research nurses but may also support retention within hospital and healthcare systems. 27 During the pandemic, much of the direct appreciation for staff was provided to staff in direct care of COVID-19 patients.…”

“…Clinical research nurses supporting decentralized (remote) clinical trials are highly autonomous and may work separately from the research team as they deliver investigative treatments from home-based or community-based settings 26 . This shift in CRN identity from hospital setting to remote setting requires additional efforts to promote belonging and professional feelings of mattering to the organization 16 . The culture of belonging and mattering not only is a means of reducing stress and burnout among research nurses but may also support retention within hospital and healthcare systems 27 .…”

“…However, burnout and the experiences of CRNs have yet to be explored. Understanding burnout levels and experiences is critical to developing support systems and resources for these crucial members of the healthcare team in pandemic recovery and beyond 16 …”

Clinical research nurse utilisation and role in the conduct of decentralised clinical trials: a literature review

“…The CRN is also an advocate for the participant, employing health training to be situationally aware to changes in participant condition that warrant further investigation by trial/study physicians or investigators. Overall, the role is a hybridised, all-encompassing presence in a community as an advocate, healthcare professional, researcher and liaison for participants to engage in research in a culturally aligned manner (Jones et al, 2022: 50–65).…”