National Islet Cell Consortium Coordinating Center

描述（由申请人提供）：本申请旨在建立希望之城国家医学中心信息科学部内的胰岛细胞资源（ICR）管理和生物信息学协调中心（ABCC）。 主要研究者（PI）将提供多中心研究协调、生物医学信息学和生物统计学方面的专业知识和经验，以通过实现以下具体目标来支持ICR项目目标：1）履行ICR常见的行政职能，并协调ICR活动，这些活动最好集中在一个可普遍访问的单一核心中; 2）为ICR指导委员会和信息标准小组委员会提供行政支持和监督; 3）通过协调胰岛细胞分布促进转化研究，与国家胰岛和β细胞登记处密切合作，以有效交换数据并促进细胞分布; 4）利用创新的领先技术以及安全和保密做法，容纳创建和维护综合中央数据库所需的核心信息学资源;和5）收集、管理和分析来自胰岛细胞处理和来自ICR临床试验的数据，以优化胰岛细胞分离以及人体胰岛细胞移植的安全性和有效性。 项目指导将由ABCC主任和PI Joyce Niland博士领导的团队提供，其中包括生物统计学联合主任大卫伊克尔博士和生物医学信息学联合主任道格拉斯斯塔尔博士。 这些研究人员在管理支持多中心临床试验和基础科学研究所需的生物统计学、临床试验和生物医学信息学资源方面拥有丰富的经验。 此外，他们将利用由国家研究资源中心（NCRR）资助的完全集成研究标准和技术（FIRST）计划下开发的临床试验数据管理技术，为参与该项目的10个ICR中心提供必要的信息学资源。 ABCC将根据一项合作协议与NCRR和指导委员会密切合作，该协议旨在确保在每个ICR与当地，区域和国家器官采购组织和移植登记处合作，使用当前的良好生产规范（cGMP）合规设施安全有效地开发最佳胰岛细胞移植策略。 除了提供行政支持和信息学基础设施外，ABCC还将监测ICR的cGMP和现行药物非临床研究质量管理规范（GLP）合规性，并将提供临床试验设计和统计分析方面的专业知识，以促进临床试验的开发，并分析中央数据库中的汇总数据，以优化胰岛细胞移植结果。

DESCRIPTION (provided by applicant): This application is to establish the Islet Cell Resources (ICR) Administrative and Bioinformatics Coordinating Center (ABCC) within the Division of Information Sciences at City of Hope National Medical Center. The Principal Investigator (PI) will provide expertise and experience in multi-center study coordination, biomedical informatics, and biostatistics to support the ICR project objectives by carrying out the following specific aims: 1) serving the administrative functions common to the ICRs and coordinating ICR activities that are best housed in a generally accessible single core; 2) providing administrative support and oversight to the ICR Steering Committee and an Information Standards Subcommittee; 3) promoting translational research through the coordination of islet cell distribution, interacting closely with the National Islet and Beta Cell Registry for the efficient exchange of data and facilitation of cell distribution; 4) housing the core informatics resources required to create and maintain the consolidated central database, using innovative leading technology and security and confidentiality practices; and 5) collecting, managing, and analyzing data from the processing of islet cells and from ICR clinical trials, to optimize islet cell isolation and the safety and efficacy of islet cell transplants in humans. Project direction will be provided by a team led by ABCC Director and PI Dr. Joyce Niland, and including Dr. David Ikle, Co-Director for Biostatistics, and Dr. Douglas Stahl, Co-Director for Biomedical Informatics. These investigators have extensive experience managing biostatistics, clinical trials and biomedical informatics resources required to support multi-center clinical trials and basic science investigations. In addition, they will leverage technology for clinical trials data management being developed under the Fully Integrated Research Standards and Technology (FIRST) initiative funded by National Center for Research Resources (NCRR) to provide essential informatics resources to the ten ICR centers participating in this project. The ABCC will work closely with the NCRR and the Steering Committee under a cooperative agreement designed to ensure the safe and efficient development of optimal islet cell transplantation strategies using current Good Manufacturing Practice (cGMP) compliant facilities at each ICR in collaboration with local, regional and national organ procurement organizations and transplant registries. In addition to providing administrative support and informatics infrastructure, the ABCC will monitor ICRs for cGMP and current Good Laboratory Practice (GLP) compliance and will provide expertise in clinical trial design and statistical analysis to facilitate development of clinical trials and to analyze pooled data in the central database to optimize islet cell transplant outcomes.