PURPOSE: To assess the role of the Clinical Trials Nurse (CTN) and to evaluate the quality of the job performed by Clinical Trials Nurses (CTNs) in Italy. METHODS: The study design was descriptive. The sample included 30 CTNs in Italy who were involved in conducting clinical trials in the last years. Respondents completed the Italian Clinical Trials Nursing Questionnaire (CTNQ) developed to measure frequency and importance of clinical trials nursing activities. Data analyses included descriptive statistics, Student's t-test and Chi-Square test. RESULTS: Thirty out of 34 CTNs consented to participate. Respondents were more involved in the experimental drug management, in the protocol implementation and, partially, in the informed consent process. CTNs have a marginal position with respect to the protocol assessment and planning, subject recruitment, data management. CTNs reported high rates for the importance evaluation. Number of years in the nursing role was significantly associated with data management related activities (p = 0.016). Items with minor response rate differences between frequency and importance were not statistically significant (p values ranging from 0.087 to 0.911). The CTNs reported to be autonomous and competent; however, they lack and/or do not perform some nursing-related responsibilities and/or activities. CONCLUSIONS: Although CTNs are not involved in all of the activities listed on the CTNQ, most of them are fully aware to be a key member of research teams. Overall, the Italian CTN role is mostly practical task-oriented and focuses little on data management and organizational activities.
PURPOSE: To assess the role of the Clinical Trials Nurse (CTN) and to evaluate the quality of the job performed by Clinical Trials Nurses (CTNs) in Italy. METHODS: The study design was descriptive. The sample included 30 CTNs in Italy who were involved in conducting clinical trials in the last years. Respondents completed the Italian Clinical Trials Nursing Questionnaire (CTNQ) developed to measure frequency and importance of clinical trials nursing activities. Data analyses included descriptive statistics, Student's t-test and Chi-Square test. RESULTS: Thirty out of 34 CTNs consented to participate. Respondents were more involved in the experimental drug management, in the protocol implementation and, partially, in the informed consent process. CTNs have a marginal position with respect to the protocol assessment and planning, subject recruitment, data management. CTNs reported high rates for the importance evaluation. Number of years in the nursing role was significantly associated with data management related activities (p = 0.016). Items with minor response rate differences between frequency and importance were not statistically significant (p values ranging from 0.087 to 0.911). The CTNs reported to be autonomous and competent; however, they lack and/or do not perform some nursing-related responsibilities and/or activities. CONCLUSIONS: Although CTNs are not involved in all of the activities listed on the CTNQ, most of them are fully aware to be a key member of research teams. Overall, the Italian CTN role is mostly practical task-oriented and focuses little on data management and organizational activities.