Investigation and analysis of the current status of clinical research nurses / 中国临床药理学与治疗学

AIM: To investigate and analyze the current situation and needs of clinical research nurses in China, in order to provide scientific basis for constructing a training system for research nurses, promoting standardized training, and achieving standardized management for them. METHODS:A self-made questionnaire was used to investigate 102 research nurses from nearly 70 well-known clinical trial institutions in China. The contents of the questionnaire mainly included the general information, professional experience and work content of the research nurses, the sense of accomplishment and training needs of clinical trial work. RESULTS: Among the 102 research nurses surveyed, 92.15% have a bachelor's degree or above; 53.92% of those have intermediate or higher professional titles; 74.51% of them are part-time research nurse. Among professional experiences, 19.61% have more than 10 years of clinical trial experience; 47.06%, 40.20%, and 21.17% of surveyed research nurses were authorized to participate in clinical trial drug management, sample management, and quality control; 70.59% of research nurses have a high sense of achievement in their daily work. In terms of education and training needs, clinical trial related laws and regulations, standardized training for clinical trial protocol implementation, and good clinical practice (GCP) are the three most important aspects. CONCLUSION: Clinical research nurses in China have a relatively high level of education and nursing experience, but there is still a large gap in the amount of professional full-time clinical research nurses in China. Due to the rapid development of innovative drugs and devices, as well as the urgent need to improve the clinical research system, it is necessary to establish a training, assessment, and evaluation system for research nurses that is in line with China's national conditions in order to improve the professional level of research nurses, and improve the quantity and quality of clinical trial research on innovative drugs and devices in China.

The Role and Function of Clinical Research Nurses in Anti-tumor Drug Clinical Trials for Lung Cancer Patients / 中国肺癌杂志

Clinical trials of anti-tumor drugs is not only the important way to develop new drugs, but also the most advanced treatment methods for malignant tumors, bringing survival benefits to patients. There are a large number of new anti-tumor drug clinical trials for lung cancer patients, covering a wide variety of anti-tumor drugs, and with rapid progress and high efficiency of clinical transformation. These trials could not be carried out successfully without the joint efforts of the research team, in which the research nurses also played a role that should not be underestimated. Combined with the work content of clinical research nurses, this paper introduced the post management, role function, core competence and career development prospect of clinical research nurses in the process of carrying out clinical trial of lung cancer drugs in detail. In order to provide reference for more medical institutions to carry out related work, and promote the further development of clinical research nurses to standardization and specialization.
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A retrospective pilot study comparing data from monitoring reports to identify staffing influence on protocol deviation rates

Background: Clinical research sites are hiring more non-licensed personnel to coordinate clinical trials and to replace licensed nurse counterparts. Revised regulatory documents heavily emphasize research staff training and research activity delegation of authority. The Scope and Standards of Practice for Clinical Research Nursing, published by the American Nurses’ Association and based on role delineation studies for nurses, is the guidance document for clinical research nurses participating in research activities. Policy making related to research activity delegation of authority would be informed by data that correlate protocol deviation rates with licensure and education of research staff. Protocol deviations can lead to invalid clinical trial results, adverse events, and ethical concerns related to participant risk exposure. Outcome data are lacking, which directly compare frequency of protocol deviations by licensed nurse study coordinators to deviation rates of non-licensed study coordinators.Methods: This pilot study reviewed 45 monitoring reports for 3 clinical research studies and associated research sites staffed with licensed RN study coordinators and research sites staffed with non-licensed, non-RN study coordinators to compare deviation rates related to informed consent, protocol endpoints, participant eligibility and adverse events.Results: We identified 101 deviations. Adverse event and endpoint deviations were the highest frequency. Differences were evident in overall deviation rates; however, specific deviation comparisons failed to show statistical significance due to low sample size. Conclusions: This study illustrates a useful method for planning future studies using monitoring reports for deviation tracking and comparison across staffing levels.

The Role of Clinical Research Nurses at Regional Clinical Trials Centers / 간호행정학회지

PURPOSE: This study aimed to evaluate the performance of Clinical Research Nurses (CRNs) and the importance of their roles at the Regional Clinical Trial Centers (RCTCs). Method: A questionnaire focused on the role of CRNs was crafted by a researcher and the content validity was verified by a panel of experts on clinical research. The subjects of this study were 91 CRNs and Clinical Research Coordinators (CRCs), who were Korean registered nurses working at nine RCTCs. 77 subjects yielded valid data were analyzed using descriptive analysis, the Mann-Whitney U test, Spearman's rank order correlation coefficient, and Kruskal-Wallis test. RESULTS: The performance of CRNs and the recognition in the importance of their roles were statistically significant different in age, education, CRN careers, positions, employment status and the phase of clinical trial. The role of direct caregiver was performed most often by CRNs. The role of coordinator of care and research (pre-study) was considered the most important role but performed the least frequent. CONCLUSIONS: The role of CRNs can easily be differentiated from CRCs who are not registered nurses. The domains of CRNs should be clearly identified and established. Moreover, research should be carried out on CRN training programs to cultivate competence in CRNs.