This is the most comprehensive study in the Clinical Research Nurse (CRN) profession in China, with a clear definition of CRN.
Introduction:
Recently, “Journal of Research in Nursing” published “A Survey of Work Status and Competency of Clinical Research Nurses in China” one article. This is the most comprehensive study carried out in China in the clinical research nurse (Clinical Research Nurse, CRN) profession, with a clear definition of CRN.
The study was led and completed by Liu Yanfei, Chairman of IACRN Shanghai-China Chapter and Director of the Clinical Trials Office of Fudan University Cancer Hospital.
Principal investigator introduction:
Liu Yanfei
Director, Office of Clinical Trials, Fudan University Cancer Hospital
NMPA Clinical Trial Data On-Site Verification Inspector
IACRN Shanghai-China Chapter/President of the International Research Nurses Organization, China Shanghai Chapter
Clinical Research Nurse (CRN) Definition
The current definition of clinical research nurses in China is: clinical research nurses are nurses who are professionally engaged in clinical research, mainly engaged in clinical research project management, coordination and/or execution of subjects’ treatment according to the research protocol. Nursing, focusing on the balance between subject protection and study protocol compliance.
Research background and methods
Clinical research is an important part of medical research, the foundation of drug safety, and an important part of addressing unmet medical needs in humans. High-quality clinical research requires the cooperation of members with strong professionalism, standardized management and systematic training. CRN refers to the transactional staff who are authorized by the principal investigator (PI) and have passed relevant training to assist investigators in making non-medical judgments in clinical trials. To some extent, they can independently participate in the coordinated management and organization of clinical trials. in progress.
The number of clinical trials registered in China increased from 940 in 2015 to 2019 (CDE, 2021), maintaining a trend of continuous increase. With the increase in the number of clinical trials, while the demand for CRNs continues to increase, higher requirements are also placed on the professional level of CRNs. What is the work status and role competency of clinical research nurses in China, and do they meet the needs of current clinical trials? At present, there are few domestic related research reports.
In this context, this study included the questionnaires of 638 people with nursing professional background for analysis, from the occupation status, job content, skills and training, subjective satisfaction of the population and the status of cooperation in the industry. Five dimensions were used to investigate the current status of clinical research nurses in China. The article summarizes the characteristics of 12 groups of domestic clinical research nurses. For the first time, the advantages and disadvantages of CRN are classified into different departments. At the same time, the special status of the surveyed population in the corresponding industry competency behavior and knowledge matching is found. Provides a baseline reference for standard setting and normative development.
Study Results
A total of 819 potential CRNs responded to our survey. The criteria for inclusion in the final analysis of this study were that respondents must be a nursing major in a nursing school or higher and more than 50% of their work time was devoted to clinical trial-related activities. Of the 819 respondents, 638 (77.9%) met our pre-specified CRN definition/criteria.
In terms of the types of departments they belong to, 638 CRNs come from 4 different types of departments: 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:
1. Of the 638 CRNs, 627 (98.28%) were female and only 11 (1.72%) were male; mean age was 35 years.
2. These 638 CRNs come from 58 cities in China. According to the definition of China’s city level, they are most distributed in first-tier cities (49.37%) or emerging first-tier cities (30.41%) (Wang et al. ., 2021) (Table 2). The highest proportion of CRNs in first-tier and emerging first-tier cities came from SMOs (96.43%, 81/84).
3. In this study, 499 (78.21%) had a bachelor’s degree in nursing, 88 (13.79%) had a nursing-related bachelor’s degree, and 44 (6.90%) had a master’s degree or above Bachelor of Science. A higher percentage of CRNs working in HCTOs had a bachelor’s degree or higher than the other three affiliations (Table 3):
4. CRNs have an average of 5.67 years of research experience; however, two-thirds of CRNs have less than 6 years of clinical research experience:
5. Three-quarters of CRNs have an annual income of RMB 150,000 (about $23,000): 274 (42.95%) have an annual income of between RMB 100,000 and RMB 150,000 During the period, 211 people (33.07%) had an annual income of less than RMB 100,000. The expected annual income after three years is mainly RMB 150,000 to RMB 200,000 (n=242, 37.93%) and RMB 200,000 to RMB 300,000 (n=210, 32.92%). The distribution patterns of current and expected annual income of CRNs vary slightly by affiliation (Table 5).
6. 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 total weekly work hours. There was no significant difference in weekly workload among non-affiliated CRNs. The average proportion of weekly workload for HND CRNs not related to clinical research is higher than for CRNs in other departments.
7. 59.56% (380/638) of CRNs have experience in international multi-center trials, and 65.67% have experience in oncology clinical trials. Compared with HND, HCD, and HCTO (52.08%, 67.50%, and 55.03%, respectively; Table 7), CRNs from SMO had the highest proportion (80.95%) of experience in international multicenter trials. The average number of clinical trials in which CRNs participated was 9.62 (Table 8), of which, on average, these CRNs participated in 4.1 international multicenter trials and 5.12 oncology clinical trials. CRNs from the HCTO participated in more clinical trials (12.83 on average) than CRNs from the other three affiliations (8.11, 7.76, and 10.25, respectively). However, CRNs from HCD were the most experienced in oncology clinical trials (mean 7.23), compared with CRNs in the other three sectors (SMO 3.03, HND 4.33 and HCTO 5.90, respectively; Table 8).
CRN participated in an average of 5.84 ongoing clinical trials during the survey period. CRNs from SMOs participated in the least number of trials (average 3.90) and CRNs from HCTOs participated in the highest number of trials (average 7.04) (Table 8).
8. The majority of CRNs (77.50%) from the four employment entities were certified in GCP training within the past five years (Table 9).
9. A higher proportion of CRNs from HCTOs received multiple training sessions (≥4, between 2016 and 2018, including voluntary and mandatory training), (Table 10). Compared with CRNs in other affiliations (≤60.95%), SMO CRNs showed a higher willingness to receive training, and SMO CRNs participated in a higher proportion of voluntary training (≥4 times, between 2016 and 2018) ( 64.28%).
10. Chinese CRNs have the highest satisfaction with job achievement (7.34) and the least satisfaction with job income (6.15). Satisfaction scores for CRNs vary by the type of entity they employ. 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 638 CRNs included in the analysis were analyzed, and the average self-assessment score of knowledge competency on a 100-point scale was 68.99, and the average self-assessment score of behavioral competency was 70.67. In modules such as adherence to EC standards, leadership and professional development, and financial management, CRN knowledge was scored lower than behavioural scores. However, they scored higher on Knowledge than on Behavior in the Contract Compliance, Documentation and Administration modules (Figure 2).
Figure 2
Based on a 2019 survey study in China (N=638), the displayed CRN knowledge and performance self-assessment radar chart. The questionnaire was based on the Oncology Nursing Society (2016) Oncology Clinical Trials Nurses Competency Model (blue dashed lines/dots represent self-assessed intellectual competency scores, orange solid lines/dots represent self-assessed behavioral competency scores. For nine of the ONS models Categories were assessed: ethical principles, contractual compliance, informed consent, subject recruitment, subject management, document management, data management and information technology, financial management, leadership and professional development.
CRN career motivation
CRN chooses this career at CRN for a variety of reasons. The most common reasons (≥10 responses) were: interest in clinical research/clinical trials (n=131), expanding current responsibilities (n=77), seeing the career as of great value, and wanting to contribute to clinical research/new drugs Contribute more to development/society (n=57), want to know more about clinical research/new drug development/gain new knowledge (n=54), no night shift pressure of clinical nursing work (n=27), and feel this Careers have a bright future and follow industry trends (n=11).
Conclusion:
In conclusion, with the booming clinical trial industry in China in recent years, the demand for more qualified CRNs is also rising. However, few studies describe the profiles of CRN employees in China. To our knowledge, this is the first large-scale investigation of CRN in China. The findings describe the Chinese CRN workforce, which is primarily composed of female nurses who work in the nursing department, clinical department, or clinical trial office of an SMO or hospital. Most of these CRNs hold a bachelor’s degree. Most of the CRNs come from large cities in China, which are also the concentrated areas of clinical trial activities. Compared to Western countries, Chinese CRNs are younger and relatively inexperienced (especially in terms of knowledge). However, these Chinese CRNs are generally well-educated, highly 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 informative summaries for policy, practice and/or research:
China’s CRN population is relatively young, with an average age of 35 years, mainly in first-tier cities and emerging first-tier cities. A bachelor’s degree is the most common educational background for CRNs. The average number of years of research experience for CRNs varies slightly across employment entities. The overall CRN population is relatively young, with an average age of 35 years.
CRNs had the highest job satisfaction while working with investigators, followed by CRCs, followed by CRAs. Overall, CRNs in China reported the highest satisfaction with job fulfillment and the lowest satisfaction with job earnings.
CRN has some gaps in knowledge and performance. Overall, the largest gaps were in EC principles, leadership and professional development, and the smallest gaps were in data management and information technology.
The most common reasons Chinese CRNs chose this career were “interest in clinical research/clinical trials”, “expanding current responsibilities”, and “believing the career is of great value and wanting to contribute to clinical make greater contributions to research/new drug development”.
Source | Mace Academic
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