臨床研究護理師對臨床試驗之認知與工作概況

Clinical Research Nurses' Knowledge and Practice in Clinical Trials

臨床研究護理師在臨床試驗中扮演重要的角色。因應國內臨床試驗案的增加，臨床研究護理師人數近幾年快速成長，但仍欠缺其執行臨床試驗現況的調查以利未來專業發展之參考。故本研究採問卷調查法，以瞭解國內臨床研究護理師的工作現況、臨床試驗的認知與執行工作職責的困境。結果發現，79位受訪者每天平均工作10小時，其中直接照護病人之工作約6小時，其次為行政文書工作、試驗相關的資料處理與傳送試驗相關資料的交通往返時間。90％以上的受訪者對未預期之嚴重藥品不良反應通報、藥物儲存以及試驗相關的查核與監測有正確認知；然而低於50％的受訪者對臨床研究護理師的進階職責、成藥安全性、以及臨床試驗的設計與考量有正確認知。臨床研究護理師的角色定位不清與欠缺專業能力的培訓為執行進階工作職責的障礙。國內醫療機構應重視臨床研究護理師的角色，且將其納入正式護理教育的範疇，使臨床研究護理師有更多接受正式專業養成之管道，進而奠定其在醫療照護體系的發展。

Clinical research nurse (CRN) has an important role in clinical trials. There has been a rapid increase in the number of nurses working as CRNs because of the increasing demand for clinical trials in Taiwan. However, there is lack of investigation to explore CRNs' knowledge and clinical practice regarding clinical trials. The study aimed to explore CRNs' knowledge, clinical practice and challenges regarding clinical trials. A questionnaire survey was conducted with 79 CRNs in a medical center in Taipei City. The average working hours of CRNs were 10 hours per day. CRNs' priority work was to take care of patients which took CRNs approximately 6 hours per day, followed by paperwork (mean=99.6 minutes), data management (85.1 minutes), and delivery of relevant trial documents between different departments (mean=60.3 minutes). Over 90% of respondents correctly answered how to report unexpected and serious adverse reactions, store study drugs, and know the purposes of inspection and monitor. Over 50% of respondents incorrectly answered CRNs' advanced responsibility, the safety of over-the counter medicines, the design and concerns of clinical trials, and procedures to terminate study drugs. The lack of articulating roles and professional training are main barriers to CRN's advanced responsibility. The roles of CRN should be emphasized and CRN's relevant training should be integration into the nursing curriculum to assist CRNs to have more opportunities receiving formal professional training and support.