Chronic Kidney Disease (CKD) Biomarkers Consortium Data Coordinating Center

慢性肾脏病 (CKD) 生物标志物联盟数据协调中心

• 批准号: 9333344
• 负责人: HAROLD I FELDMAN
• 金额: $ 47.09万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-18 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9333344
• 关键词: Address; Biological Assay; Biological Markers; Biometry; Cardiovascular Diseases; Chronic Kidney Failure; Clinical; Clinical Trials; Communication; Data; Data Coordinating Center; Databases; Development; Disease Pathway; Disease Progression; Documentation; End stage renal failure; Enrollment; Epidemic; Event; Financial cost; Future; Geography; Goals; Grant; Healthcare Systems; Intervention; Kidney Diseases; Laboratories; Lead; Leadership; Logistics; Methodology; Monitor; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Outcome; Outcome Measure; Patient risk; Patients; Phase; Pilot Projects; Protocols documentation; Quality Control; Randomized Clinical Trials; Renal function; Report (document); Reporting; Research; Research Design; Research Project Grants; Resources; Role; Science; Signal Transduction; Source; Structure; Teleconferences; Testing; United States; Validation; biomarker discovery; biomarker identification; design; effective intervention; epidemiology study; follow-up; high risk; implementation research; interest; meetings; member; mortality; multidisciplinary; novel marker; professional atmosphere; programs; public health relevance; quality assurance; repository; success; tool; web site

DESCRIPTION (provided by applicant): The proposed coordinating center for the CKD Biomarkers Consortium (BioCon) will support scientific development and implementation of a broad array of research protocols conducted by Participating Centers and pilot grant awardees. The BioCon Scientific and Data Coordinating Center (SDCC) will enhance biomarker science in CKD by providing expertise and leadership in epidemiological study design, biostatistics, laboratory science, stewardship of biosample resources drawn from geographically dispersed sources, and the collaborative implementation of protocols conducted by the diverse members of the BioCon research network. The specific aims of the BioCon SDCC include: 1) To enhance biomarker research in CKD by providing scientific and laboratory leadership and coordination in the design and implementation of research protocols across the CKD BioCon network, 2) To provide biostatistical expertise in research designs, outcome measures and to perform analyses for development, validation and qualification of biomarkers for CKD, 3) To provide comprehensive SDCC administrative and logistical support for CKD BioCon, promoting effective communications (within the Steering Committee, with NIDDK, with NIDDK's External Expert Panel), coordinating and supporting teleconferences, meetings, subcommittees, scientific reports, and document development and management, maintaining a website, and preparing standard and special reports of consortium activities, 4) To coordinate and track the transfer of data and biospecimens between members of the consortium and appropriate repositories, and to establish a comprehensive database of information from approved CKD BioCon protocols, 5) To promote network-wide quality assurance standards, practices and tools, and engage in quality control of biospecimen assays throughout the consortium, and 6) To develop, implement, and monitor a CKD BioCon Pilot and Feasibility Projects program, and to support the conduct of the pilot studies.

描述（由申请人提供）：拟议的CKD生物标志物联盟（BioCon）协调中心将支持参与中心和试点赠款获得者开展的一系列广泛的研究方案的科学发展和实施。BioCon科学和数据协调中心（SDCC）将通过在流行病学研究设计、生物统计学、实验室科学、地理分散来源的生物样本资源管理以及由BioCon研究网络的不同成员进行的协议的协作实施方面提供专业知识和领导，加强CKD的生物标志物科学。BioCon SDCC的具体目标包括：1)通过在整个CKD BioCon网络的研究方案的设计和实施中提供科学和实验室的领导和协调，加强CKD的生物标志物研究；2)在研究设计，结果测量方面提供生物统计学专业知识，并为CKD生物标志物的开发，验证和鉴定进行分析；3)为CKD BioCon提供全面的SDCC行政和后勤支持。促进有效的沟通（在指导委员会内，与NIDDK，与NIDDK的外部专家小组），协调和支持电话会议，会议，小组委员会，科学报告，文件的开发和管理，维护一个网站，准备联盟活动的标准和特别报告。4)协调和跟踪数据和生物标本在联盟成员和适当的存储库之间的转移；5)推广网络范围内的质量保证标准、实践和工具，并在整个联盟中参与生物标本分析的质量控制；6)制定、实施和监测CKD BioCon试点和可行性项目计划，并支持试点研究的开展。