Schroeder Clinical Research Consulting, LLC, Phoenix, AX.
Semin Oncol Nurs. 2020 Apr;36(2):151002. doi: 10.1016/j.soncn.2020.151002. Epub 2020 Apr 4.
To describe the increasing complexity and scope of clinical trials research, convergent research, and the clinical nurse roles and responsibilities to ensure safe patient care and study data integrity.
Textbooks, journal publications, federal regulations, US Food and Drug Administration documents, clinical practice guidelines.
The immune system, genetics, and molecular pathology are not new in the context of oncology treatments. The reliability and clinical validation of in vitro diagnostic medical devices is, however, becoming increasingly more important in the development of marker driven targeted therapies, immunotherapy, and adoptive T-cell transfer. Protecting patients and preserving the integrity of clinical trials is of utmost importance.
The role and scope of oncology and research nurses will intersect and shift as clinical care continues to involve high-acuity patients who participate in complex in vitro diagnostic and therapeutics clinical trials. The expertise of oncology nurses may vary in skills and knowledge domain; however, all scopes of practice are underpinned by the nursing code of ethics to ensure accountability for all aspects of patient care.
描述临床试验研究、趋同研究以及临床护士角色和职责的日益复杂性和广泛性，以确保患者安全和研究数据的完整性。
教科书、期刊出版物、联邦法规、美国食品和药物管理局文件、临床实践指南。
免疫系统、遗传学和分子病理学在肿瘤治疗中并不是新的。然而，在开发标志物驱动的靶向治疗、免疫疗法和过继性 T 细胞转移方面，体外诊断医疗器械的可靠性和临床验证变得越来越重要。保护患者和维护临床试验的完整性至关重要。
随着临床护理继续涉及参与复杂的体外诊断和治疗临床试验的高风险患者，肿瘤学和研究护士的角色和范围将交叉和转变。肿瘤护士的专业知识可能在技能和知识领域有所不同；然而，所有实践范围都以护理伦理准则为基础，以确保对患者护理的所有方面负责。
