Ness Elizabeth A, Royce Cheryl
Office of Education and Compliance, Center for Cancer Research, National Cancer Institute, 10 Center Drive, Room 3-2571, MSC 1206, Bethesda, MD 20892, USA.
Office of Research Nursing, Center for Cancer Research, National Cancer Institute, 10 Center Drive, Room 3-2571, MSC 1206, Bethesda, MD 20892, USA.
Nurs Clin North Am. 2017 Mar;52(1):133-148. doi: 10.1016/j.cnur.2016.10.005.
Clinical trials are paramount to improving human health. New trial designs and informed consent issues are emerging as a result of genomic profiling and the development of molecularly targeted agents. Many groups and individuals are responsible for ensuring the protection of research participants and the quality of the data produced. The specialty role of the clinical trials nurse (CTN) is critical to clinical trials. Oncology CTNs have competencies that can help guide their practice; however, not all oncology clinical trials are supervised by a nurse. Using the process of engagement, one organization has restructured oncology CTNs under a nurse-supervised model.
临床试验对于改善人类健康至关重要。由于基因组分析和分子靶向药物的发展，新的试验设计和知情同意问题不断涌现。许多团体和个人负责确保研究参与者得到保护以及所产生数据的质量。临床试验护士（CTN）的专业角色对临床试验至关重要。肿瘤学CTN具备有助于指导其工作的能力；然而，并非所有肿瘤学临床试验都由护士监督。通过参与过程，一个组织已在护士监督模式下对肿瘤学CTN进行了重组。
