The Rockefeller University Navigation Program: A Structured Multidisciplinary Protocol Development and Educational Program to Advance Translational Research
The Rockefeller University Navigation Program: A Structured Multidisciplinary Protocol Development and Educational Program to Advance Translational Research
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DOI：
10.1111/cts.12134
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发表时间：
2014-02-01
影响因子：
3.9
通讯作者：
Coller, Barry S.
中科院分区：
文献类型：
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作者：
Brassil, Donna;Kost, Rhonda G.;Coller, Barry S.
临床转化研究方案的发展是复杂的。为了帮助研究人员，我们开发了一个结构化的支持性指导过程（导航），以加快方案的制定，达到良好临床实践（GCP）的标准，重点是研究伦理和完整性。导航由经验丰富的研究协调员领导研究人员通过协调一致的多步骤方案开发过程，从概念发起到提交最终方案。为了评估导航的有效性，我们收集了调查人员的经验、方案制定所需的支持强度、IRB审查结果以及方案开始和完成日期的数据。自2007年该项目开始以来，144项研究方案通过了导航并获得了IRB的批准，其中37项由实习研究员领导，26项由医学博士领导，9项由医学博士/博士领导，57项由博士领导，12项由具有其他证书的研究人员（如注册护士、公共卫生硕士）领导。每年，超过50%的导航协议在30天内得到IRB的批准。对于有多个导航协议的受训者，所需的导航支持强度随着时间的推移而降低。导航可以增加基础科学家获得转化研究的机会，促进对研究人员的GCP培训，并加速制定和批准具有高道德和科学质量的方案。
The development of translational clinical research protocols is complex. To assist investigators, we developed a structured supportive guidance process (Navigation) to expedite protocol development to the standards of good clinical practice (GCP), focusing on research ethics and integrity. Navigation consists of experienced research coordinators leading investigators through a concerted multistep protocol development process from concept initiation to submission of the final protocol. To assess the effectiveness of Navigation, we collect data on the experience of investigators, the intensity of support required for protocol development, IRB review outcomes, and protocol start and completion dates. One hundred forty-four protocols underwent Navigation and achieved IRB approval since the program began in 2007, including 37 led by trainee investigators, 26 led by MDs, 9 by MD/PhDs, 57 by PhDs, and 12 by investigators with other credentials (e.g., RN, MPH). In every year, more than 50% of Navigated protocols were approved by the IRB within 30 days. For trainees who had more than one protocol navigated, the intensity of Navigation support required decreased over time. Navigation can increase access to translational studies for basic scientists, facilitate GCP training for investigators, and accelerate development and approval of protocols of high ethical and scientific quality.