National Islet Cell Consortium Coordinating Center

这项建议是建立胰岛细胞资源(ICR)行政和生物信息协调中心 (ABCC)，在希望之城国家医学中心的信息科学部。我们将提供 在支持多中心研究协调、生物医学信息学和生物统计学方面的专业知识和经验 通过执行以下具体目标实现ICR项目目标：1)服务于行政职能 这是国际报告的共同之处，并协调国际报告的活动，这些活动最好放在一个普遍可访问的单一核心中。2) 向ICR指导委员会和信息标准小组提供行政支持和监督- 委员会审议阶段。3)通过协调胰岛细胞分布、相互作用促进翻译研究 与国家小岛/Beta单元登记处密切合作，以便有效地交换数据和便利单元 分发。4)提供创建和维护合并的中央信息系统所需的核心信息资源 数据库，使用创新的领先技术和安全/保密做法，以及5)收集、管理、 并分析来自胰岛细胞处理和ICR临床试验的数据，以优化胰岛细胞分离和 人类胰岛细胞移植的安全性和有效性。项目指导将由一个由 ABCC董事兼首席研究员Joyce Nland博士，包括 生物统计学博士和生物医学信息学联席主任道格拉斯·斯塔尔博士。这些调查人员有广泛的 具有管理生物统计、临床试验管理和生物医学信息学资源的经验 支持多中心临床试验和基础科学研究。此外，他们还将利用技术 在完全集成的研究标准和技术下开发的临床试验数据管理 (一)由NCRR资助的倡议，向十个岛屿单元资源(ICR)提供必要的信息资源 参与该项目的中心。ABCC将在以下方面与NCRR和指导委员会密切合作 旨在确保安全高效地开发最佳胰岛细胞的合作协议 在每个ICR使用符合cGMP的设施，与当地、地区和 国家器官采购组织和移植登记处。除了提供行政支持外 和信息基础设施，ABCC将监测ICR的cGMP和cGLP合规性，并将提供 在临床试验设计和统计分析方面的专长，以促进临床试验的发展和分析 将数据汇集在中央数据库中，以优化胰岛细胞移植的结果。

This proposal is to establish the Islet Cell Resources (ICR) Administrative and BioinformaUcs Coordinating Center (ABCC) within the Division of Information Sciences at City of Hope National Medical Center. We 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 Sub- Committee. 3) promoting translational research through the coordination of islet cell distribution, interacting closely with the National Islet/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/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 Principal Investigator Dr. Joyce Niland, and including Dr. David Ik16, Co-Director for Biostatistics, and Dr, Douglas Stahl, Co-Director for Biomedical Informatics. These investigators have extensive experience managing biostatistics, clinical trials management 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 NCRR to provide essential informatics resources to the ten Islet Cell Resource (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 cGMP compliant facilities at each ICR in collaboration with local, regioinal and national organ procurement organizations and transplant registries. In addition to providing administrative support and informatics infrastruscture, the ABCC will monitor ICRs for cGMP and cGLP 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.