Kidney Health Initiative is a public-private partnership between the American Society of Nephrology, US Food and Drug Administration and the kidney community.

肾脏健康倡议是美国肾脏病学会、美国食品和药物管理局以及肾脏界之间的公私合作伙伴关系。

• 批准号: 10449098
• 负责人: Tod Ramses Ibrahim
• 金额: $ 30万
• 依托单位: AMERICAN SOCIETY OF NEPHROLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10449098
• 关键词: Kidney; Health; Initiative; public; private

Project Summary/Abstract The Kidney Health Initiative (KHI) is a public-private partnership between the American Society of Nephrology (ASN), US Food and Drug Administration (FDA), and all major stakeholders in the kidney community (patients, healthcare professionals, members of industry and government). KHI is the largest consortium in the kidney community and is focused on addressing barriers to the development of new drugs, devices and biologics for people living with kidney disease. KHI's Board of Directors and project workgroups discuss and develop solutions for barriers as they are identified by the membership and community. Solutions include but are not limited to opportunities to elucidate clinical trial endpoints, improve clinical trial design and execution, to develop diagnostic markers and patient registries, to create avenues for closer collaboration with the US Food and Drug Administration (FDA) and other stakeholders, and to advance awareness and inclusion of people living with kidney diseases into drug, device and biologic development. The application will outline support for the future roadmaps and projects, expansion of the patient and family partnership and KHI infrastructure, such as the project submission process and annual stakeholders meeting. The current grant proposal plans to build upon the initial successes of the KHI and take our collaboration with the FDA to the next level in terms of organization, scope and impact.

项目摘要/摘要 肾脏健康倡议(KHI)是美国肾脏学会之间的公私合作伙伴关系 (ASN)、美国食品和药物管理局(FDA)以及肾脏界的所有主要利益相关者(患者、 医疗保健专业人员、行业和政府成员)。KHI是肾脏中最大的财团 致力于解决开发新药、设备和生物制品的障碍 患有肾脏疾病的人。KHI董事会和项目工作组讨论和开发解决方案 对于障碍，因为它们是由成员和社区识别的。解决方案包括但不限于 阐明临床试验终点、改进临床试验设计和执行、开发的机会 诊断标记和患者登记，为与美国食品和药物管理局更紧密的合作创造途径 美国食品和药物管理局(FDA)和其他利益攸关方，并提高对艾滋病患者的认识和纳入 肾脏疾病分为药物、器械和生物开发。该应用程序将概述对未来的支持 路线图和项目、扩大患者和家庭伙伴关系以及KHI基础设施，如 项目提交流程和年度利益相关者会议。目前的拨款提案计划建立在 KHI的初步成功，并将我们与FDA的合作在组织方面提升到了一个新的水平， 范围和影响。