二十五年来,通过合作解决最前沿的科学、政策和监管问题:合作研究论坛。

IF 3.1 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Cts-Clinical and Translational Science Pub Date : 2024-10-19 DOI:10.1111/cts.70051
Robin Schaefer, Alessi Ayvaz, Christopher R. Hoffman, Margot Yann, Zachary Rooney, Mitchell Leus, Shilpa Mitra, Veronica Miller, for the Forum for Collaborative Research
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引用次数: 0

摘要

开发安全有效的药物和其他医疗产品是一个复杂且成本高昂的过程。从历史上看,药物开发通常都是竞争性的,缺乏合作,而这种利益相关者--制药业、学术界、监管机构、医疗服务提供者和社区等--之间缺乏互动的趋势可能导致错失提高效率的机会,最终影响公众健康。合作研究论坛成立于 1997 年,旨在通过多方利益相关者的参与和对话,解决当前全球健康领域的科学、政策和监管问题。通过提供一个中立、安全的讨论空间,论坛的模式影响了不同健康领域临床试验的开展方式,支持了更广泛、更公平的临床试验参与,并加快了新药的交付。随着时间的推移,论坛的重点和方向也发生了变化,这种对全球卫生界需求的响应对于确保论坛继续支持全球卫生领域的合作至关重要。在本文中,我们将介绍论坛 25 年来开创的合作研究与监管科学这一创新模式的经验教训,包括所有利益相关方集体所有和管理的重要性,以及强调合作的共同目标和优势。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Twenty-five years of addressing cutting-edge scientific, policy, and regulatory issues through collaboration: The Forum for Collaborative Research

Developing safe and effective drugs and other medical products is a complex and costly process. Drug development has been, historically, commonly competitive and uncollaborative, and this tendency toward a lack of interaction between stakeholders—the pharmaceutical industry, academia, regulatory agencies, healthcare providers, and communities, among others—can lead to missed opportunities to improve efficiency and, ultimately, public health. The Forum for Collaborative Research was established in 1997 to address current scientific, policy, and regulatory issues in global health through multistakeholder engagement and dialogue. By providing a neutral and safe space for discussion, the Forum's model has impacted how clinical trials in diverse health areas are conducted, supported broader and more equitable clinical trial participation, and accelerated delivery of new drugs. The Forum's focus and directions have shifted over time, and this responsiveness to the needs of the global health community will be critical to ensure that the Forum continues to support collaboration in global health. In this article, we present lessons learned from this innovative model of collaborative research and regulatory science, pioneered by the Forum for over 25 years, including the importance of collective ownership and governance by all stakeholders, and emphasis on common goals and advantages of collaboration.

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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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