3.1 The development of CRNs in China is in its infancy and is receiving increasing attention
Internationally, CRNs first appeared in the United States in the 1970s, It first appeared in university affiliated hospitals, large public hospitals and large research institutions. It is mainly served by research doctors, pharmacists, testers, nurses and other personnel with biomedical professional background. Nurses are the best choice for this role,and were widely accepted and developed in Europe, the United States and Japan because of their great contribution to the quality and efficiency of clinical trials . Since the 1990s, there has been a global boom in clinical research, and the development of multinational, multicentre collaborative clinical studies has led to prosperous growth in CRNs. In 2007, the United States began to build a conceptual model of clinical research nursing practice areas, standardised and described the work of CRNs, the education and training concept and management decision-making mechanism of CRNs have been relatively mature . In addition, the definition, job content, inclusion and training standards of CRNs have been practiced and explored to varying degrees in the United Kingdom, Japan, New Zealand and Italy [16,18,19].
CRNs in China emerged around the 1990s, with a late start and slow development . This can also be seen from the content of the published literature between 1992 and 2003, which mainly introduced the basic information and working experience of foreign CRNs in the medical nursing branch. The earliest report of CRN practice in China was published during the clinical trial of a new class Ι drug invented in China in 1999, which suggests that nurses played an essential role in ensuring the smooth conduct of the trial from the nursing perspective . In 2005, at the National Oncology Nursing Academic Exchange Meeting of the Chinese Nursing Association, the term CRN was used for the first time, and the role and professional characteristics of CRNs in drug clinical trials were standardised . Since then, the exploration and practice of CRNs in China have entered a new stage. Since 2005, the number of articles on CRNs has increased significantly, and the issues of concern include the problems of CRNs in clinical trials, the role played at various key points in the trials, the introduction and reflection of domestic and foreign experiences and the in-depth discussion on the cultivation and management of CRNs in China. The CRNs in China has gradually developed from part-time to full-time staff  and work in hospitals at all levels with national clinical trial qualifications.
An overview of the development of CRNs in China reveals that the number and quality of studies conducted on them have increased significantly, reflecting that the status and role of CRNs in clinical trials are more recognised, valued and play an important role in guiding the summary of the initial exploration work and the direction of future development. However, it is clear from the characteristics of the authors and institutions that the practice and exploration of CRNs in China are regionalised and unevenly influenced by various factors, such as the level of urban development and health policy orientation, and the overall level of research still needs to be improved, with more exploratory and empirical articles published, and less empirical research in line with China’s national conditions. Therefore, in general, the development of CRNs in China is still in its initial stage, but the attention and importance are increasing.
3.2 Clarifying the role and scope of work is a central theme in the development of CRNs
Whether by the statistics of keyword frequency and mediated centrality or by the interpretation of keyword clustering analysis and emergence, ‘clinical research’, ‘research nurse’, ‘drug clinical trial’ and ‘management’ were all hot words in the literature published in China about CRNs. Through the analysis of these hot terms and combined with the literature where the keywords were found, it was discovered that most of them were discussions on the professional orientation and job responsibilities of CRNs, including both the reference to the advanced experience of foreign developed countries and the practical summary of localisation in China.
In fact, at the early stage of drug clinical trial development in China, CRNs and clinical research coordinators (CRCs) were not distinguished and were defined in general terms as staff members authorised by the principal investigator and trained to coordinate investigators in clinical research for non-medical judgemental matters [6,23]. However, this definition does not reflect the importance of CRNs in ensuring the quality of clinical research and the safety of subjects, and therefore the perception of the role of CRNs is ambiguous and not conducive to their development . A clear professional orientation is essential for nurses to actively participate in clinical practice, establish positive self-understanding and improve professional identity, further enhancing the quality of care and professional satisfaction [3,25-28]. Clarifying the role and scope of work of CRNs is of great significance to the development of this professional field. The role orientation, role functions and practice areas of CRNs were all explored and studied in developed Western countries in the early 1990s .
With the introduction and implementation of CRC industry guidelines in China, the occupational scope of CRNs and CRCs has been further defined, and the occupational scope of CRNs is more inclined to protect subjects and nursing operations related to clinical trials. Some domestic scholars [3,30-33] have already investigated and practiced CRN job categories that meet China’s national conditions and hospital development needs and have initially constructed a framework for CRN core job competencies. In addition, ‘Consensus of Experts on Clinical Research Nurse Management in China’ released in June 2021 is a detailed description of the definition, job settings and qualifications, duties and tasks, training and assessments, job quantifications and manpower allocation performance assessments and promotion of CRNs. This is a milestone on the road to the standardised development of CRNs in China and lays the foundation for its future standardised management and employment.
3.3 Specialisation is the future direction of CRN development
The keywords related to CRNs in China with high emergence intensity found in this study were ‘new drug’, ‘nursing staff’, ‘clinical research assistant’, ‘bioequivalence’ and ‘clinical research nurse’, and ‘bioequivalence’ and ‘clinical research coordinator’ continued to emerge so far, which indicates that nurses play an essential role throughout China’s drug clinical trials. This puts forward higher requirements for the practice and exploration of the professional development of CRN positions, including position management, performance appraisal, promotion, etc. The exploration in this field will be the future research direction for the development of CRNs in China.
The CRNs nursing practice is focused on maintaining a balance between trial subject care and compliance with the study protocol . The CRN also plays the role of educator, advocate, partner, data collector, direct caregiver, liaison, interpreter and observer in clinical trials, which is very challenging and complex, requiring leadership and organisational skills . However, these skills are beyond the scope of traditional specialty nursing, and there are no teaching arrangements to match them in our current nursing education system. Throughout the development of research nurses in Europe, the United Kingdom, Japan and other developed countries, they have continuously established and improved their education and training systems , not only by increasing the number of research practical training courses and providing internship opportunities in universities and colleges to develop practical nursing skills but also by providing online training and continuing education courses in various institutions to improve their critical thinking skills, making them better adapt to their roles and career development. Therefore, there is an urgent need for nursing institutions to construct relevant education and training programs and courses based on the core competencies and developmental needs of CRNs.
The development of the profession cannot be separated from a sound management system of inclusion, training and assessment. A sound management system can include more excellent talents for the CRN team and bring ongoing vitality to the profession. With the flourishing development of clinical trials in China and the emergence of more full-time CRNs as an extension of the field of nursing specialties, questions arise as to how to select, train, employ and evaluate the management of CRNs, and how to adopt a reasonable incentive mechanism to bring the role of CRNs in nursing work and research into play. The field of practice for CRNs is unlike that of clinical wards, and there are differences between various specialties, so the requirements for their core and job competencies are different, which urgently requires health administration departments as well as medical institutions to establish sound job inclusion criteria, evaluation of work, continuing education and performance appraisals. Improving the appraisals plays a crucial role in the career development of this profession [37,38].
As an emerging nursing professional role, the development of CRNs also requires the establishment of an academic community to promote the sharing of research results and practical experience among peers at home and abroad so that the training, employment and management of CRNs can gradually embark on a scientific and standardised path and contribute nursing power to the high-level development of clinical research in China.
In summary, the CRN is currently in a period of rapid development, and a single-core research pattern has been formed, which has played a strong leading role in the development of CRNs. In the future, cross-regional authors and inter-institutional cooperation need to be strengthened to narrow the regional development gap and to promote and popularise rigorous and standardised clinical nursing methods nationwide to improve the quality of clinical nursing research results. In recent years, clinical nursing research has focused on clinical trials, and the scope of research needs to be expanded. It can be started from education and management to change the concept of clinical nurses’ experience-based care, strengthen continuing education about clinical nursing courses and effectively improve the practical ability of CRNs to provide more scientific and high-quality nursing services to patients.