This is the most comprehensive study conducted in China in the clinical research nurse (CRN) specialty area, with a clear definition of CRN.
Guide:
Recently, the Journal of Research in Nursing published an article entitled "A Survey of Work Status and Competency of Clinical Research Nurses in China". This is the most comprehensive study conducted in China in the clinical research nurse (CRN) specialty area, with a clear definition of CRN.
The study was led by Yanfei Liu, Chairman of THEIACRN Shanghai-China Chapter and Director of the Clinical Trial Institution Office of Fudan University Cancer Hospital.
Introduction of the main investigators:
Liu Yanfei
Director of the Office of Clinical Trial Institutions of the Affiliated Cancer Hospital of Fudan University
State Drug Administration Clinical trial data on-site verification inspector
IACRN Shanghai-China Chapter/International Research Nurses Organization, Shanghai, China
Clinical Research Nurse (CRN) definition
The current definition of Clinical Research Nurse in China is: Clinical Research Nurse is a nursing staff specializing in clinical research, mainly engaged in clinical research project management, coordination and/or implementation of subject treatment care according to the research protocol, and pay attention to the balance between subject protection and research protocol compliance.
Research background and methodology
Clinical research is an important part of medical research, the foundation of drug safety and an important part of addressing the unmet medical needs of human beings. High-quality clinical research requires the cooperation of members with strong professionalism, standardized management and systematic training. CRN refers to the transactional staff who assist researchers in making non-medical judgments in clinical trials after being authorized by the principal investigator (PI) and relevant training, and can independently participate in the coordination management and organizational implementation of clinical trials to some extent.
The number of clinical trials registered in China rose from 940 in 2015 to 2019 (CDE, 2021), maintaining a continuous upward trend. With the increase in the number of clinical trials, the demand for CRN continues to increase, and higher requirements are also put forward for the professional level of CRN. What is the current status and role competence of clinical research nurses in China, and does it meet the needs of current clinical trials? At present, there are few reports of relevant research in China.
In this context, the survey included the answer sheets of 638 people with nursing professional backgrounds, and investigated the current situation of clinical research nurses in China from five dimensions: occupational status, work content, skills and training, subjective satisfaction of the population and the status quo of industry post cooperation. This paper summarizes the characteristics of 12 populations in the domestic clinical research nurse group, conducts a classification study on the advantages and disadvantages of the management mode of different departments under crN ownership for the first time, and finds the special status quo of the surveyed population in the competence behavior and knowledge matching of the corresponding industry, in order to provide a baseline reference for the formulation of industry standards and the development of norms.
Research results
A total of 819 potential CRNs responded to our survey. The criteria for the final analysis included in this study were that respondents must be nursing majors in a nursing school or higher, and that more than 50% of their time was spent on clinical trial-related activities. Of the 819 respondents, 638 (77.9%) met our pre-set CRN definitions/criteria.
In terms of the type of divisions under which they belong, 638 CRNs came from four different types of sectors: SMO (n=84,13.17%), HND*(n=265,41.54%), HCD*(n=120, 18.81%), and HCTO*(n=169,26.49%).
*Hospital clinical trial office (HCTO); hospital nursing department (HND) and; hospital clinical department (HCD)
Distribution, basic information and professional experience:
Of the 638 CRNs, 627 (98.28%) were females and only 11 (1.72%) were males; the average age was 35 years.
These 638 CRNs are from 58 cities in China, and are most distributed in first-tier cities (49.37%) or emerging first-tier cities (30.41%) according to the definition of China's city hierarchy (Wang et al., 2021) (Table 2). CrNs in tier-1 and emerging tier cities had the highest percentage of SMOs (96.43%, 81/84).
In this study, 499 (78.21%) had a bachelor's degree in nursing, 88 (13.79%) had a bachelor's degree in nursing, and 44 (6.90%) had a master's degree or above. CrNs working at HCTOs have a higher proportion of bachelor's degree or above compared to the other three subordinations (Table 3):
The average research experience of CRNs is 5.67 years; however, two-thirds of CRNs have less than 6 years of clinical research experience:
Three-quarters of the CRNs have an annual income of 150,000 yuan (about $23,000): 274 (42.95%) have annual incomes between 100,000 and 150,000 yuan, and 211 (33.07%) have annual incomes of less than 100,000 yuan. The expected annual income after three years is mainly 150,000 to 200,000 yuan (n=242,37.93%) and 200,000 to 300,000 yuan (n=210,32.92%). The distribution pattern of current and expected annual income of CRNs varies slightly from different sub-sectors (Table 5).
CRNs work an average of 45.46 hours per week (Table 6). Clinical trial-related activities accounted for 62.68% of CRN's weekly workload. Clinical trial-related work accounted for 51.98% to 79.96% of CRN's total workload, while workload unrelated to clinical research accounted for 37.32% of the total weekly work time. CrNs, which are not affiliated, do not have a significant difference in weekly workload. The average proportion of weekly workloads of HND CRNs unrelated to clinical studies is higher than crNs in other departments.
7. 59.56% (380/638) of CRNs have experience in international multi-center trials, and 65.67% have experience in clinical trials of tumors. Compared with HND, HCD and HCTO (52.08%, 67.50% and 55.03% respectively; Table 7), crNs from SMOs had the highest proportion of international multicenter trial experience (80.95%). The average number of clinical trials in which CRNs participated was 9.62 (Table 8), of which these CRNs participated in an average of 4.1 international multicenter trials and 5.12 tumor clinical trials. CRNs from HCTO participated in more clinical trials (an average of 12.83) than crNs from the other three subsectors (8.11, 7.76 and 10.25, respectively). However, CRNs from HCD were the most experienced in tumor clinical trials (average 7.23) compared to CRNs in the other three sectors (SMO 3.03, HND 4.33, and HCTO 5.90; Table 8, respectively).
During the survey period, crNs participated in an average of 5.84 ongoing clinical trials. CRNs from SMOs participated in the fewest trials (average 3.90) and CRNs from HCTOs had the highest number of trials (average 7.04) (Table 8).
The majority of CRNs (77.50%) from the four employment entities have obtained GCP training certifications in the past five years (Table 9).
A high percentage of CRNs from HCTOs received multiple trainings (≥ 4, between 2016 and 2018, including voluntary and mandatory training) (Table 10). Compared with crNs in other subordinate departments (≤60.95%), the CRNs of SMOs showed a higher willingness to receive training, and the proportion of PARTICIPANTs in voluntary training in SMO CRNs was higher (4 ≥, between 2016 and 2018) (64.28%).
10. China CRNs had the highest satisfaction with their sense of accomplishment at work (7.34) and the least satisfied with their work income (6.15). CRNs' satisfaction scores vary depending on the type of entity they hire. In terms of belonging, HCTO had the highest average CRN score and SMO had the lowest CRN score (Table 12).
CRN competency assessment
According to the ONS 2016 Competency Model, the average score of the 638 CRNs included in the analytical study was 68.99 for the knowledge competency self-assessment on a 100-point scale and 70.67 for the behavioral competency self-assessment. In modules such as COMPLIANCE with EC Standards, Leadership and Professional Development, and Financial Management, CRN knowledge is scored lower than the behavioral score. However, their knowledge scores in the Contract Compliance, Documentation, and Management modules were higher than their behavior scores (Figure 2).
Figure 2
According to a 2019 China study (N=638), a radar chart of CRN knowledge and behavioral ability self-assessment is shown. The questionnaire is based on the Society of Oncology Nursing (2016) Oncology Clinical Trial Nurse Competency Model (blue dotted line/dot represents self-assessment knowledge ability score, orange solid line/dot represents self-assessment behavioral ability score). Nine categories in the ONS model were evaluated: Ethical Principles, Contractual Compliance, Informed Consent, Subject Recruitment, Subject Management, Document Management, Data Management and Information Technology, Financial Management, Leadership, and Professional Development.
CRN's motivation to choose a career
CrNs choose this career for CRNs for a wide variety of reasons. The most common reasons (≥10's response) are: interest in clinical research/clinical trials (n=131), expansion of current responsibilities (n=77), belief that the profession has great value and a desire to make a greater contribution to clinical research/new drug development/society (n=57), want to learn more about clinical research/new drug development/access to new knowledge (n=54), no pressure to work at night for clinical nursing jobs (n=27), and feel that the profession has a bright future and follow industry trends (n=54). 11）。
conclusion:
In short, with the vigorous development of China's clinical trial industry in recent years, the demand for more qualified CRNs is also rising. However, few studies have described the profile of CRN employees in China. To our knowledge, this is the first large-scale survey of CRNs in China. The findings describe the Chinese CRN workforce, which consists mainly of female nurses who work in THE NURSING DEPARTMENT, CLINICAL DEPARTMENT OR CLINICAL TRIAL OFFICE OF AN SMO OR HOSPITAL. Most of these CRNs have bachelor's degrees. CRNs are mostly from large Chinese cities and are also a region where clinical trial activity is concentrated. Compared to Western countries, CRNs in China are younger and relatively inexperienced (especially in terms of knowledge). However, these Chinese CRNs are generally well-educated, very motivated, and eager for professional and professional development. The results of this study have been used to design training courses for CRNs in China to bridge the gap between their knowledge and behavior.
This survey provides a summary of policy, practice and/or research that can be used for reference:
China's CRN population is relatively younger, with an average age of 35 years old, mainly distributed in first-tier cities and emerging first-tier cities. Bachelor's degrees are the most common educational background in CRNs. The average number of years of research experience in CRNs varies slightly from employed entity to employment. The CRN population as a whole is younger, with an average age of 35 years.
During its work with investigators, CRNs had the highest job satisfaction, followed by the CRC and followed by the CRA. Overall, CRNs in China have the highest satisfaction with a sense of accomplishment at work and the lowest satisfaction with work income.
CRNs have some gaps in knowledge and behavioral capacity. Overall, gaps in EC principles, leadership and professional development are the largest, while gaps in data management and information technology are the smallest.
The most common reasons for CRNs to choose this profession in China are "interest in clinical research/clinical trials", "expanding current responsibilities", and "believing that the profession is of great value and wanting to make greater contributions to clinical research/new drug development".
Source | Metz Academic
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