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临床试验研究的历史:对肿瘤护士的启示。

The History of Clinical Trials Research: Implications for Oncology Nurses.

机构信息

Our Lady of the Lake Regional Medical Center, Baton Rouge, LA.

Kelly Willenberg, LLC, Greenville, SC.

出版信息

Semin Oncol Nurs. 2020 Apr;36(2):150997. doi: 10.1016/j.soncn.2020.150997. Epub 2020 Mar 19.

DOI:10.1016/j.soncn.2020.150997
PMID:32201023
Abstract

OBJECTIVE

To discuss the major milestones in the history of clinical research and how these correlate with the role of the clinical research nurse.

DATA SOURCES

Government Web sites, published articles, and grey literature.

CONCLUSION

The history of clinical research, drug development, and the regulations has come of age, and as a result clinical oncology research has a more defined scope and purpose. With the Oncology Nursing Society and the International Association of Clinical Research Nurses recognizing the scopes of practice for clinical research nursing, such roles are becoming more prevalent and integrated in oncology.

IMPLICATIONS FOR NURSING PRACTICE

It is vital for all clinical research nurses to understand and adhere to the laws and regulations related to clinical trials and human subject protection. The clinical research nurse must ensure good clinical practice and compliance with the regulations to ensure the integrity of the study. There are different types of clinical research, including behavioral, therapeutic, and nontherapeutic studies, where clinical research nurses must understand the treatments and the drug development process to better serve their patients.

摘要

目的

讨论临床研究史上的主要里程碑,以及这些里程碑与临床研究护士的作用有何关联。

资料来源

政府网站、已发表文章和灰色文献。

结论

临床研究、药物开发和法规的历史已经成熟,因此临床肿瘤学研究有了更明确的范围和目的。随着肿瘤护理学会和国际临床研究护士协会认识到临床研究护理的实践范围,这种角色在肿瘤学中变得更加普遍和综合。

对护理实践的意义

所有临床研究护士都必须了解并遵守与临床试验和人体受试者保护相关的法律和法规。临床研究护士必须确保良好的临床实践和法规的遵守,以确保研究的完整性。有不同类型的临床研究,包括行为、治疗和非治疗性研究,临床研究护士必须了解治疗方法和药物开发过程,以便更好地为患者服务。

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