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Cancer Clinical Trials: Implications for Oncology Nurses
被引:5
|作者:
Portier, Wendy S.
[1
]
机构:
[1] Portier & Associates LLC, New Orleans, LA USA
关键词:
clinical trial;
Food and Drug Administration;
biomarker;
informed consent;
protocol;
adverse event;
clinical trial navigator;
D O I:
10.1016/j.soncn.2020.150998
中图分类号:
R73 [肿瘤学];
学科分类号:
100214 ;
摘要:
Objective: To explore the various types and phases of clinical trials, the regulatory oversight, drug approval process, and implications of clinical trials for the oncology nurse. Data Sources: Peer-reviewed journal articles, internet, book chapters, white papers. Conclusion: Oncology nurses' interactions with patients entered on clinical trial and communication with the clinical research team is crucial to the successful conduct of clinical trials. The oncology nurse must work in concert with the clinical research team to protect patient safety and to produce accurate information for protocol requirements that will be used to evaluate whether a drug becomes approved or not by the US Food and Drug Administration. Implications for Nursing Practice: Oncology nurses play a central role to the successful outcome of clinical research studies. Nurses must work in close collaboration with the clinical research teams for the successful completion and adherence of the clinical trial and to maintain the safety of the patient enrolled into clinical trial. (C) 2020 Elsevier Inc. All rights reserved.
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