Bozzetti Mattia, Guberti Monica, Lo Cascio Alessio, Privitera Daniele, Genna Catia, Rodelli Silvia, Turchini Laura, Amatucci Valeria, Giordano Luciana Nicola, Mora Vincenzina, Napolitano Daniele, Caruso Rosario
Department of Biomedicine and Prevention, University of Rome Tor Vergata, 00133 Rome, Italy.
Allied Health Professions Directorate, Orthopedic Research Institute, 40136 Bologna, Italy.
Nurs Rep. 2025 Jul 24;15(8):266. doi: 10.3390/nursrep15080266.
: Clinical Research Nurses (CRNs) have emerged as pivotal actors in the conduct, coordination, and oversight of clinical trials globally. Over the past three decades, the role of the CRN has evolved in response to the increasing complexity of research protocols, ethical standards, and regulatory frameworks. Originating as task-oriented support figures, CRNs have progressively assumed broader responsibilities that include patient advocacy, protocol integrity, ethical vigilance, and interprofessional coordination. By mapping the global literature on CRNs, this review will examine how their role has been defined, implemented, and evaluated over the past three decades. : A scoping review was conducted using JBI methodology and PRISMA-ScR guidelines. The search covered the peer-reviewed and gray literature from 1990 to 2024 across major databases. Data analysis combined traditional extraction with topic modeling, Multiple Correspondence Analysis, and k-means clustering to identify key themes. : From the 128 included studies, four major themes emerged: clinical trial management, role perception and team integration, professional competencies and development, and systemic barriers. Despite formal competency frameworks, CRNs face inconsistencies in role recognition, unstable contracts, and limited career pathways. Emotional strain and professional isolation are recurrent. Over time, their functions have evolved from task execution to broader responsibilities, including advocacy and ethical oversight. However, no studies reported patient-level outcomes, revealing a critical gap in the evidence base. : CRNs play a vital but undervalued role in clinical research. Persistent structural challenges hinder their development and visibility. Enhancing institutional support and generating outcome-based evidence are necessary steps toward fully integrating CRNs into research infrastructures.
临床研究护士(CRNs)已成为全球临床试验开展、协调和监督的关键角色。在过去三十年中,CRN的角色随着研究方案、伦理标准和监管框架日益复杂而不断演变。CRNs最初是面向任务的支持人员,逐渐承担了更广泛的职责,包括患者权益倡导、方案完整性维护、伦理警觉和跨专业协调。通过梳理关于CRNs的全球文献,本综述将考察其角色在过去三十年中是如何被定义、实施和评估的。
采用JBI方法和PRISMA-ScR指南进行了一项范围综述。检索涵盖了1990年至2024年各大数据库中的同行评审文献和灰色文献。数据分析将传统提取方法与主题建模、多重对应分析和k均值聚类相结合,以确定关键主题。
在纳入的128项研究中,出现了四个主要主题:临床试验管理、角色认知与团队整合、专业能力与发展以及系统性障碍。尽管有正式的能力框架,但CRNs在角色认可方面存在不一致、合同不稳定且职业发展路径有限。情绪压力和职业孤立屡见不鲜。随着时间的推移,他们的职能已从任务执行演变为更广泛的职责,包括倡导和伦理监督。然而,没有研究报告患者层面的结果,这揭示了证据基础中的一个关键差距。
CRNs在临床研究中发挥着至关重要但却被低估的作用。持续存在的结构性挑战阻碍了他们的发展和知名度。加强机构支持并生成基于结果的证据是将CRNs全面纳入研究基础设施的必要步骤。