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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.
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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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Humans , Antineoplastic Agents/therapeutic use , Lung Neoplasms/drug therapyABSTRACT
Objetivo: descrever experiências de enfermeiros empreendedores empresariais. Método: Trata-se de um relato de múltiplas experiências de enfermeiros com empreendimentos em diferentes regiões do Brasil. As narrativas das experiências foram descritas pelos autores em julho de 2021. Resultados: As experiências relatam que para o desenvolvimento de seus empreendimentos foram necessárias ações como: planejamento, dedicação, investimento em educação, preocupação permanente com as práticas baseadas em evidências científicas, conhecimento de legislação e elaboração de plano de negócios. Também foi descrito que é igualmente importante coragem de arriscar, autoconfiança, não ter medo de falhar, buscar informações, estabelecer parcerias com pessoas que são autoridades no assunto que se deseja empreender. Considerações finais: Empreender na enfermagem é buscar a transformação pessoal, profissional e da categoria, em busca de uma profissão mais forte, com mais visibilidade social em um processo em que essa transformação repercute em crescimento pessoal, valorização profissional e reconhecimento do trabalho.
Objective: to describe the experiences of entrepreneurial nurse practitioners. Method: This goal was met by listening to the different experiences lived by nurses with companies are mainly located in different regions of Brazil. The description provided by them was assessed and processed in July, 2021. Results: Some critical factors to the development of their business were identified herein, which include planning actions, dedication, investment in education, permanent seeking of practices based on scientific evidence, knowledge of legislation and development of a business plan. The participants also described that it is equally important to take risks, to have self-confidence, not to be afraid of failing, to seek information, to establish partnerships with people who are very knowledgeable in the subject that one wishes to undertake. Final considerations: becoming an entrepreneurial nurse demands a constant search for personal, professional and class transformation, as well as the pursuit of a stronger and socially visible nursing profession, in a process where this transformation has an impact on personal growth, professional valorization and work recognition.
Objetivo: describir las experiencias de enfermeros emprendedores de negocios. Método: Este es un relato de múltiples experiencias de enfermeros con emprendimientos en diferentes regiones de Brasil. Las narrativas de las experiencias fueron descritas por los autores en julio de 2021. Resultados: Las experiencias relatan que para el desarrollo de sus emprendimientos fueron necesarias acciones con planificación, dedicación, inversión en educación, preocupación permanente por prácticas basadas en evidencia científica, conocimiento de legislación y desarrollo de planes de negocios. También se describió que es igualmente importante correr el riesgo, tener confianza en sí mismo, no tener miedo a fallar, buscar información, establecer alianzas con personas que son autoridades en el tema que se desea emprender. Consideraciones finales: Emprender en enfermería es buscar la transformación personal, profesional y de categoría, en busca de una profesión más fuerte, con más visibilidad social, en un proceso donde esta transformación repercute en el crecimiento personal, la valorización profesional y reconocimiento laboral.
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Humans , Entrepreneurship , Nursing Administration Research , Nursing , Nurse's Role , Nurse AdministratorsABSTRACT
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.
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OBJECTIVE:To study the influencing factors of protocol deviation in drug clinical trial implementation,and pro-vide reference for improving the quality of drug clinical trial. METHODS:Quality verification was conducted for the drug clinical trial projects in the First Affiliated Hospital of Chongqing Medical University during 2010-2016,and protocol deviations in each year were retrospectively studied,classified and analyzed. Category,frequency,international and domestic pilot projects and the differences of protocol deviation after full-time research nurse participating in trail management were explored,and the measures were put forward. RESULTS:27 drug clinical trials were implemented in our hospital during 2010-2016,including 949 cases,176 cases with protocol deviation,accounting for 18.55％. Deviation protocol in drug clinical trial was decreased year by year for 7 years. The categories were mainly incompleteness of observation/records (30.11％),checking omission/broaden the window(28.41％),adverse drug events and improper combined medication (14.20％) and omission in drug management (11.93％). The proportion of protocol deviation with full-time research nurse participated was lower than the projects without full-time research nurse(11.11％ vs. 28.67％,P<0.01),and proportion of deviation protocol in international multi-center project was lower than the domestic projects(6.60％ vs. 28.84％,P<0.01). CONCLUSIONS:It is suggested to pointedly strengthen the weak links of drug clinical trial. For example,clinical trial institutions should establish the clinical trial data retention system,electronic data should be timely backed up in a different places,etc. Besides,clinical trial institutions should equip professional full-time research nurses as much as possible,learn the rigorous scientific experimental design,standard operational procedures and the authenticity of data pro-cessing from the international multi-center clinical trial projects to effectively reduce the incidence of deviation protocol and im-prove the quality of drug clinical trials.
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PURPOSE: The purpose of this study was to identify the level of project perception for those nurses from research-driven hospitals and to analyze the effect of research-relevant performance in the health care field focusing on the mediated effect of research capacity and job satisfaction. METHODS: Data were collected from June, 2014 to July, 2014, and participants were 106 research nurses in Research-driven hospitals. Descriptive statistics, Independent t-test, One-way ANOVA, structural equation modeling (SEM). RESULTS: As a result, Research-relevant performance according to project perception of research nurses from Research-driven Hospitals was not statistically significant, but research capacity and job satisfaction had a mediating role. Evaluation System Perception was significantly different from Research Capacity (p<.001), Research Capacity was significantly different from Job Satisfaction (p<.001), Job Satisfaction was significantly different from Research Performance (p<.001) CONCLUSION: The results indicate that research capacity building and job security research nurses are able to contribute to improving research performance of research-driven hospitals.
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Capacity Building , Delivery of Health Care , Job Satisfaction , NegotiatingABSTRACT
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.