临床研究网络:JHCRN基础设施和经验教训。

IF 2.8 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Cts-Clinical and Translational Science Pub Date : 2025-01-22 DOI:10.1111/cts.70123
Rahul Kashyap, Gayane Yenokyan, Robert Joyner, Melissa Gerstenhaber, Mary Alderfer, Erika Siegrist, Joan Moore, Channing J. Paller, Hanan Aboumatar, James J. Potter, Stanley Watkins Jr, John E. Niederhuber, Daniel E. Ford, Adrian Dobs
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引用次数: 0

摘要

临床研究变得越来越复杂,导致工作负担加重,研究周期延长,每一个都加剧了失控的成本。协议复杂性的影响往往导致招募不足和样本量不足,这挑战了有效性和普遍性。临床研究网络(CRN)在美国和世界其他地区已经被提出并启动,人们认识到需要提供另一种模式来吸引研究人员和赞助商,并为更广泛的社区带来临床研究机会。约翰霍普金斯临床研究网络(JHCRN)成立于2009年,是学术医疗中心和社区医院/卫生系统之间的多疾病研究合作。我们讨论了愿景、治理、基础设施、参与医院的特点以及在建立这种伙伴关系过程中吸取的经验教训。JHCRN旨在利用有组织的患者社区、以社区为基础的调查人员和学术研究人员,为大西洋中部地区的9个卫生系统提供快速研究。它拥有一个备案的内部审查委员会、一个集中的合同办公室和一群专门的网络协调员,促进了研究伙伴关系,以扩大一个地区不同规模和类型的医院/卫生系统之间的研究合作。截至2024年8月,在NIH、私人基金会和工业界的资助下,共进行了81项研究——临床试验、队列研究和比较有效性研究。JHCRN的经验增强了对参与站点和相关门诊实践的复杂性的理解。总之,CRN作为一个学术社区伙伴关系,为多种疾病研究提供了基础设施,分担了风险,并增加了研究者和志愿者的参与。
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Clinical Research Network: JHCRN Infrastructure and Lessons Learned

Clinical research studies are becoming increasingly complex resulting in compounded work burden and longer study cycle times, each fueling runaway costs. The impact of protocol complexity often results in inadequate recruitment and insufficient sample sizes, which challenges validity and generalizability. Understanding the need to provide an alternative model to engage researchers and sponsors and bringing clinical research opportunities to the broader community, clinical research networks (CRN) have been proposed and initiated in the United States and other parts of the world. We report on the Johns Hopkins Clinical Research Network (JHCRN), established in 2009 as a multi-disease research collaboration between the academic medical centers and community hospitals/health systems. We have discussed vision, governance, infrastructure, participating hospitals' characteristics, and lessons learned in creating this partnership. Designed to leverage organized patient communities, community-based investigators, and academic researchers, the JHCRN provides expedited research across nine health systems in the mid-Atlantic region. With one IRB of record, a centralized contracting office, and a pool of dedicated network coordinators, it facilitates research partnerships to expand research collaborations among the differing sizes and types of hospitals/health systems in a region. As of August 2024, total 81 studies-clinical trials, cohort studies, and comparative effectiveness research have been conducted, with funding from the NIH, private foundations, and industry. The JHCRN experience has enhanced understanding of the complexity of participating sites and associated ambulatory practices. In conclusion, the CRN, as an academic–community partnership, provides an infrastructure for multiple disease studies, shared risk, and increased investigator and volunteer engagement.

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来源期刊
Cts-Clinical and Translational Science
Cts-Clinical and Translational Science 医学-医学:研究与实验
CiteScore
6.70
自引率
2.60%
发文量
234
审稿时长
6-12 weeks
期刊介绍: Clinical and Translational Science (CTS), an official journal of the American Society for Clinical Pharmacology and Therapeutics, highlights original translational medicine research that helps bridge laboratory discoveries with the diagnosis and treatment of human disease. Translational medicine is a multi-faceted discipline with a focus on translational therapeutics. In a broad sense, translational medicine bridges across the discovery, development, regulation, and utilization spectrum. Research may appear as Full Articles, Brief Reports, Commentaries, Phase Forwards (clinical trials), Reviews, or Tutorials. CTS also includes invited didactic content that covers the connections between clinical pharmacology and translational medicine. Best-in-class methodologies and best practices are also welcomed as Tutorials. These additional features provide context for research articles and facilitate understanding for a wide array of individuals interested in clinical and translational science. CTS welcomes high quality, scientifically sound, original manuscripts focused on clinical pharmacology and translational science, including animal, in vitro, in silico, and clinical studies supporting the breadth of drug discovery, development, regulation and clinical use of both traditional drugs and innovative modalities.
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