Article (Scientific journals)
Uncovering the Professional Landscape of Clinical Research Nursing: A Scoping Review with Data Mining Approach
Bozzetti, Mattia; Guberti, Monica; Lo Cascio, Alessio et al.
2025In Nursing reports, 15 (8)
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Keywords :
barriers; clinical research nursing; clinical trials; competencies; professional identity; alertness; clinical practice guideline; clinical research; correspondence analysis; data base; data mining; human; k means clustering; landscape; nurse; patient advocacy; practice guideline; Preferred Reporting Items for Systematic Reviews and Meta-Analyses; research protocol; review; scoping review; systematic review
Abstract :
[en] Background/Objectives: 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. Methods: 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. Results: 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. Conclusions: 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. © 2025 by the authors.
Disciplines :
Nursing Science
Author, co-author :
Bozzetti, Mattia;  Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, 00133, Italy
Guberti, Monica;  Allied Health Professions Directorate, Orthopedic Research Institute, Bologna, 40136, Italy
Lo Cascio, Alessio;  Direction of Health Professions, La Maddalena Cancer Center, Palermo, 90146, Italy
PRIVITERA, Daniele  ;  University of Luxembourg > Faculty of Science, Technology and Medicine (FSTM) > Department of Life Sciences and Medicine (DLSM) > Medical Education ; Department of Cardiovascular, Neural and Metabolic Sciences, Istituto Auxologico Italiano, IRCCS, San Luca Hospital, Milan, 20149, Italy
Genna, Catia;  Professional Development, Continuing Education and Research Unit, Bambino Gesù Children’s Hospital (IRCCS), Rome, 00165, Italy
Rodelli, Silvia;  CEMAD—Fondazione Policlinico Gemelli, IRCCS, Rome, 00168, Italy
Turchini, Laura;  CEMAD—Fondazione Policlinico Gemelli, IRCCS, Rome, 00168, Italy
Amatucci, Valeria;  CEMAD—Fondazione Policlinico Gemelli, IRCCS, Rome, 00168, Italy
Giordano, Luciana Nicola;  CEMAD—Fondazione Policlinico Gemelli, IRCCS, Rome, 00168, Italy
Mora, Vincenzina;  CEMAD—Fondazione Policlinico Gemelli, IRCCS, Rome, 00168, Italy
Napolitano, Daniele;  CEMAD—Fondazione Policlinico Gemelli, IRCCS, Rome, 00168, Italy
Caruso, Rosario;  Department of Biomedical Sciences for Health, University of Milan, Milan, 20133, Italy ; Health Professions Research and Development Unit, IRCCS Policlinico San Donato, 20097 San Donato Milanese, Italy
External co-authors :
no
Language :
English
Title :
Uncovering the Professional Landscape of Clinical Research Nursing: A Scoping Review with Data Mining Approach
Publication date :
2025
Journal title :
Nursing reports
ISSN :
2039-4403
eISSN :
2039-439X
Publisher :
Multidisciplinary Digital Publishing Institute (MDPI)
Volume :
15
Issue :
8
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBilu :
since 26 November 2025

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