Division of Extramural Science Programs, National Institute of Nursing Research, Bethesda, MD.
Nurs Outlook. 2018 Sep;66(5):470-472. doi: 10.1016/j.outlook.2018.02.001. Epub 2018 Feb 23.
Pragmatic clinical trials are used to test the efficacy of interventions in a real-world clinical practice setting.
The purpose of this article was to summarize the presentation given at the Council on Advancement of Nursing Science 2017 Meeting.
Key science focus areas of the National Institute of Nursing Research (NINR) and the National Institutes of Health (NIH) guidelines relevant to pragmatic clinical trials were reviewed.
The NIH supports some large-scale pragmatic trials and NINR participates in two of them. Generally, the NINR supports small-scale pragmatic trials that are a mission fit with the NINR. Now pragmatic trials are subject to the new NIH clinical trial requirements.
Investigators must respond to a specific clinical trial announcement and use the new clinical trial application forms. The NINR program staff are a valuable resource to answer questions that investigators may have regarding their pragmatic clinical trial proposal.
实用临床试验用于在真实临床实践环境中测试干预措施的疗效。
本文旨在总结在 2017 年护理科学促进会会议上的演讲内容。
回顾了美国国立卫生研究院(NIH)指南中与实用临床试验相关的国家护理研究所(NINR)的重点科学领域。
NIH 支持一些大型实用临床试验,NINR 参与其中两个。通常,NINR 支持与 NINR 使命相符的小规模实用临床试验。现在,实用临床试验需要遵守 NIH 的新临床试验要求。
研究者必须对特定的临床试验公告做出回应,并使用新的临床试验申请表。NINR 项目工作人员是回答研究者在实用临床试验提案中可能遇到的问题的宝贵资源。