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.
机构:
Case Western Reserve Univ, Sch Med, Dept Family Med & Community Hlth, Cleveland, OH 44106 USA
Case Western Reserve Univ, Case Comprehens Canc Ctr, Cleveland, OH 44106 USACase Western Reserve Univ, Sch Med, Dept Family Med & Community Hlth, Cleveland, OH 44106 USA
Flocke, Susan A.
Antognoli, Elizabeth
论文数: 0引用数: 0
h-index: 0
机构:
Case Western Reserve Univ, Sch Med, Dept Family Med & Community Hlth, Cleveland, OH 44106 USACase Western Reserve Univ, Sch Med, Dept Family Med & Community Hlth, Cleveland, OH 44106 USA
Antognoli, Elizabeth
Daly, Barbara J.
论文数: 0引用数: 0
h-index: 0
机构:
Case Western Reserve Univ, Case Comprehens Canc Ctr, Cleveland, OH 44106 USA
Case Western Reserve Univ, Frances Payne Bolton Sch Nursing, Cleveland, OH 44106 USACase Western Reserve Univ, Sch Med, Dept Family Med & Community Hlth, Cleveland, OH 44106 USA
Daly, Barbara J.
Jackson, Brigid
论文数: 0引用数: 0
h-index: 0
机构:
MetroHlth Syst, Cleveland, OH USACase Western Reserve Univ, Sch Med, Dept Family Med & Community Hlth, Cleveland, OH 44106 USA
Jackson, Brigid
Fulton, Sarah E.
论文数: 0引用数: 0
h-index: 0
机构:
Case Western Reserve Univ, Case Comprehens Canc Ctr, Cleveland, OH 44106 USA
Case Western Reserve Univ, Sch Med, Cleveland, OH USACase Western Reserve Univ, Sch Med, Dept Family Med & Community Hlth, Cleveland, OH 44106 USA
Fulton, Sarah E.
Liu, Tasnuva M.
论文数: 0引用数: 0
h-index: 0
机构:
Case Western Reserve Univ, Case Comprehens Canc Ctr, Cleveland, OH 44106 USA
Case Western Reserve Univ, Sch Med, Cleveland, OH USACase Western Reserve Univ, Sch Med, Dept Family Med & Community Hlth, Cleveland, OH 44106 USA
Liu, Tasnuva M.
Surdam, Jessica
论文数: 0引用数: 0
h-index: 0
机构:
Case Western Reserve Univ, Case Comprehens Canc Ctr, Cleveland, OH 44106 USA
Case Western Reserve Univ, Sch Med, Cleveland, OH USACase Western Reserve Univ, Sch Med, Dept Family Med & Community Hlth, Cleveland, OH 44106 USA
Surdam, Jessica
Manne, Sharon
论文数: 0引用数: 0
h-index: 0
机构:
Rutgers Canc Inst New Jersey, New Brunswick, NJ USACase Western Reserve Univ, Sch Med, Dept Family Med & Community Hlth, Cleveland, OH 44106 USA
Manne, Sharon
Meropol, Neal J.
论文数: 0引用数: 0
h-index: 0
机构:
Case Western Reserve Univ, Case Comprehens Canc Ctr, Cleveland, OH 44106 USA
Flatiron Hlth, Res Oncol, New York, NY USACase Western Reserve Univ, Sch Med, Dept Family Med & Community Hlth, Cleveland, OH 44106 USA
机构:
Sichuan Univ, Div Head & Neck & Mammary Oncol, Dept Med Oncol, Canc Ctr,State Key Lab Biotherapy,W China Hosp, Chengdu 610041, Peoples R ChinaSichuan Univ, Div Head & Neck & Mammary Oncol, Dept Med Oncol, Canc Ctr,State Key Lab Biotherapy,W China Hosp, Chengdu 610041, Peoples R China
Zhang, Jie
Zhang, Hong
论文数: 0引用数: 0
h-index: 0
机构:
Sichuan Univ, Div Head & Neck & Mammary Oncol, Dept Med Oncol, Canc Ctr,State Key Lab Biotherapy,W China Hosp, Chengdu 610041, Peoples R ChinaSichuan Univ, Div Head & Neck & Mammary Oncol, Dept Med Oncol, Canc Ctr,State Key Lab Biotherapy,W China Hosp, Chengdu 610041, Peoples R China
Zhang, Hong
Yu, Chunhua
论文数: 0引用数: 0
h-index: 0
机构:
Sichuan Univ, Div Head & Neck & Mammary Oncol, Dept Med Oncol, Canc Ctr,State Key Lab Biotherapy,W China Hosp, Chengdu 610041, Peoples R ChinaSichuan Univ, Div Head & Neck & Mammary Oncol, Dept Med Oncol, Canc Ctr,State Key Lab Biotherapy,W China Hosp, Chengdu 610041, Peoples R China
Yu, Chunhua
Li, Junying
论文数: 0引用数: 0
h-index: 0
机构:
Sichuan Univ, Div Head & Neck & Mammary Oncol, Dept Med Oncol, Canc Ctr,State Key Lab Biotherapy,W China Hosp, Chengdu 610041, Peoples R ChinaSichuan Univ, Div Head & Neck & Mammary Oncol, Dept Med Oncol, Canc Ctr,State Key Lab Biotherapy,W China Hosp, Chengdu 610041, Peoples R China
Li, Junying
Jiang, Yu
论文数: 0引用数: 0
h-index: 0
机构:
Sichuan Univ, Div Head & Neck & Mammary Oncol, Dept Med Oncol, Canc Ctr,State Key Lab Biotherapy,W China Hosp, Chengdu 610041, Peoples R ChinaSichuan Univ, Div Head & Neck & Mammary Oncol, Dept Med Oncol, Canc Ctr,State Key Lab Biotherapy,W China Hosp, Chengdu 610041, Peoples R China
机构:
Univ Sao Paulo, Inst Canc Estado Sao Paulo, Discipline Radiol & Oncol, Sao Paulo, BrazilUniv Sao Paulo, Inst Canc Estado Sao Paulo, Discipline Radiol & Oncol, Sao Paulo, Brazil
Bariani, Giovanni M.
de Celis Ferrari, Anezka C. R.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Sao Paulo, Inst Canc Estado Sao Paulo, Discipline Radiol & Oncol, Sao Paulo, BrazilUniv Sao Paulo, Inst Canc Estado Sao Paulo, Discipline Radiol & Oncol, Sao Paulo, Brazil
de Celis Ferrari, Anezka C. R.
Precivale, Maristela
论文数: 0引用数: 0
h-index: 0
机构:
Inst Canc Estado Sao Paulo, PGS Stat, BR-01246000 Sao Paulo, BrazilUniv Sao Paulo, Inst Canc Estado Sao Paulo, Discipline Radiol & Oncol, Sao Paulo, Brazil
Precivale, Maristela
Arai, Roberto
论文数: 0引用数: 0
h-index: 0
机构:
Inst Canc Estado Sao Paulo, Climat Res Unit, BR-01246000 Sao Paulo, BrazilUniv Sao Paulo, Inst Canc Estado Sao Paulo, Discipline Radiol & Oncol, Sao Paulo, Brazil
Arai, Roberto
Saad, Everardo D.
论文数: 0引用数: 0
h-index: 0
机构:
Dendrix Res, Sao Paulo, BrazilUniv Sao Paulo, Inst Canc Estado Sao Paulo, Discipline Radiol & Oncol, Sao Paulo, Brazil
Saad, Everardo D.
Riechelmann, Rachel P.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Sao Paulo, Inst Canc Estado Sao Paulo, Discipline Radiol & Oncol, Sao Paulo, Brazil
Inst Canc Estado Sao Paulo, Climat Res Unit, BR-01246000 Sao Paulo, BrazilUniv Sao Paulo, Inst Canc Estado Sao Paulo, Discipline Radiol & Oncol, Sao Paulo, Brazil
Riechelmann, Rachel P.
AMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS,
2015,
38
(06):
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574