Data Coordinating Center for Hemodialysis Pilot Studies Consortium

血液透析试点研究联盟数据协调中心

基本信息

批准号：
9331938
负责人：
Laura M Dember
金额：
$ 20万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-15 至 2018-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9331938
关键词：
Ancillary Study Award Biometry Caring Chronic Kidney Insufficiency Clinical Clinical Trials Clinical Trials Data Monitoring Committees Comorbidity Data Data Analyses Data Collection Data Coordinating Center Databases Development Devices Dialysis procedure Electrolytes End stage renal failure Feasibility Studies Funding Future Goals Health Healthcare Systems Hemodialysis Human Resources Hypertension Image Individual Inflammation Interleukin-6 Intervention Kidney Laboratories Lead Leadership Maintenance Modification Monitor Morality Morbidity - disease rate Multicenter Studies National Institute of Diabetes and Digestive and Kidney Diseases Nephrology Outcome Outcome Measure Participant Patients Pennsylvania Pilot Projects Positioning Attribute Preparation Procedures Process Productivity Protocols documentation Publications Quality of life Randomized Clinical Trials Randomized Controlled Trials Reading Reporting Research Research Personnel Resources Safety Series Site Specimen Time Training United States National Institutes of Health Universities Work abstracting chronic pelvic pain clinical epidemiology cohort collaboratory design experience improved improved outcome inhibitor/antagonist medical schools meetings member mortality novel novel strategies novel therapeutics patient safety psychosocial quality assurance receptor repository sample collection small molecule systems research tool trial design urologic

项目摘要

DESCRIPTION (provided by applicant): The Hemodialysis Pilot Studies Consortium (HDPSC) will design and conduct pilot and feasibility studies of novel therapies to reduce morbidity and mortality for patients treated with maintenance hemodialysis. This is an application from the Center for Clinical Epidemiology and Biostatistics and the Renal, Electrolyte and Hypertension Division at the University of Pennsylvania Perelman School of Medicine to serve as the Data Coordinating Center (DCC) for the consortium. The DCC will provide scientific expertise and operational support for pilot studies that will be conducted at the HDPSC Participating Clinical Centers. Specifically, the DCC will: 1) provide scientific leadership for the design, implementation, and analysis of targeted pilot and feasibility studies conducted by the HDPSC to inform the design of future full-scale randomized, controlled trials; 2) establish network-wide quality assurance standards and practices, including training of study personnel, site monitoring, and rigorous data monitoring and management; 3) establish and apply standardized processes, procedures, and tools for the implementation of individual pilot and feasibility study protocols by consortium members; 4) provide comprehensive administrative support for consortium activities including meetings of the Steering Committee, Data and Safety Monitoring Board, and consortium subcommittees, and establish subcontracts with core laboratories, reading, and imaging centers; 5) facilitate the acceptance and/or qualification by the FDA of outcomes proposed for HDPSC studies and support regulatory requirements including those for studies conducted under an investigator IND; 6) support the preparation of scientific findings as abstracts, presentations, and publications; 7) support development of HDPSC ancillary studies, and implement a process for formal review and approval by the HDPSC Steering Committee; 8) prepare, document, and transfer consortium data to the NIDDK Data Repository; and 9) partner with HDPSC Participating Clinical Centers and the NIDDK to plan full-scale randomized controlled trials informed by the findings of the pilot and feasibility studies conducted by this consortium.

描述（由申请人提供）：血液透析试点研究联盟 (HDPSC) 将设计并开展新疗法的试点和可行性研究，以降低接受维持性血液透析治疗的患者的发病率和死亡率。这是宾夕法尼亚大学佩雷尔曼医学院临床流行病学和生物统计学中心以及肾脏、电解质和高血压部门提出的申请，作为该联盟的数据协调中心 (DCC)。 DCC 将为 HDPSC 参与临床中心进行的试点研究提供科学专业知识和运营支持。具体来说，DCC 将： 1) 为 HDPSC 进行的有针对性的试点和可行性研究的设计、实施和分析提供科学领导，为未来全面随机对照试验的设计提供信息； 2）建立全网络质量保证标准和实践，包括研究人员培训、现场监测以及严格的数据监测和管理； 3) 建立并应用标准化流程、程序和工具，用于联合体成员实施个别试点和可行性研究协议； 4) 为联盟活动提供全面的行政支持，包括指导委员会、数据和安全监测委员会以及联盟小组委员会的会议，并与核心实验室、读取和成像中心建立分包合同； 5) 促进 FDA 对 HDPSC 研究提出的结果的接受和/或鉴定，并支持监管要求，包括根据研究者 IND 进行的研究的监管要求； 6) 支持科学发现的摘要、演示文稿和出版物的准备； 7) 支持 HDPSC 辅助研究的开发，并实施 HDPSC 指导委员会正式审查和批准的流程； 8) 准备、记录联盟数据并将其传输至 NIDDK 数据存储库； 9) 与 HDPSC 参与临床中心和 NIDDK 合作，根据试点结果和可行性规划全面的随机对照试验该联盟进行的研究。