Transplantation Group

移植组

• 批准号: 9485286
• 负责人: Michelle Lynn Sever
• 金额: $ 304.78万
• 依托单位: RHO FEDERAL SYSTEMS DIVISION, INC.
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9485286
• 关键词: Achievement; Allergic Disease; Area; Asthma; Autoimmune Diseases; Biometry; Child; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Collaborations; Communication; Data; Data Coordinating Center; Data Quality; Development; Ensure; Ethics; Funding; Funding Opportunities; Genomics; Human Resources; Hypersensitivity; Immune Tolerance; Immunology; Intervention; Intervention Studies; Leadership; Manuscripts; Monitor; National Institute of Allergy and Infectious Disease; Observational Study; Organ Transplantation; Outcome; Preparation; Process; Protocols documentation; Reporting; Research; Research Infrastructure; Research Personnel; Research Support; Resources; Scientist; Services; Site; Solid; Standardization; Statistical Data Interpretation; Structure; System; Training Activity; Transplant Recipients; Transplantation; U-Series Cooperative Agreements; cost; data management; design; experience; improved; member; operation; organizational structure; programs; protocol development; rho; success

PROJECT SUMMARY/ABSTRACT—TRANSPLANTATION GROUP Through this Funding Opportunity Announcement, the NIAID Division of Allergy, Immunology and Transplantation (DAIT) intends to consolidate its funding for multiple, independent coordinating centers into a single, multi-component cooperative agreement in order to reduce costs and increase efficiency and standardization across research consortia. This new program will fund a single Center to support DAIT research in the areas of asthma and allergic diseases, autoimmune diseases, and transplantation. In the area of solid organ transplantation, the Center will support 4 consortia: Clinical Trials in Organ Transplantation (CTOT), Clinical Trials in Organ Transplantation in Children (CTOT-C), Genomics of Transplantation Cooperative Research Program (GTCRP), and the organ transplantation component of the Immune Tolerance Network (ITN). Within the Center, support for these 4 consortia will be organized under 1 group, the Transplantation Group (TG). The objective of the TG is to provide excellent and efficient study coordination support services across the transplant research consortia. To accomplish this objective, RhoFED aims to (1) provide staff experienced in transplantation research conducted by DAIT-supported consortia and to organize these staff in an administrative structure that manages resources efficiently, be responsive to the needs of the research consortia and DAIT, and facilitate communication and collaboration; (2) provide experienced scientists and statisticians who, in collaboration with clinical investigators and senior DAIT officials, will design and analyze studies across the full scope of research in transplantation; (3) facilitate the development, review, and revision of initial and successive drafts of protocols and protocol-related documents through dedicated TG protocol teams; and (4) provide study initiation and study management functions that are required for the efficient and ethical conduct of studies. Because RhoFED is currently the Statistical and Clinical Coordinating Center (SACCC) for the CTOT, CTOT-C and GTCRP consortia and is the Statistical Data Coordinating Center (SDCC) for ITN, Rho is uniquely well-qualified to provide consolidated Center support across these consortia. By providing staff with experience in supporting transplantation research, an administrative infrastructure designed to enhance collaboration between DAIT Project Officers and the consortia investigators, and a plan for agile and effective resource management, we believe that support of these consortia through the newly formed Center and its TG will directly contribute to the achievement of the DAIT objective to improve clinical outcomes following solid organ transplantation.

项目摘要/摘要-移植组 通过这一资助机会公告，NIAID过敏，免疫学和 移植（DAIT）打算将其对多个独立协调中心的资助合并为一个 单一、多组成部分的合作协定，以降低成本和提高效率， 跨研究联盟的标准化。这个新计划将资助一个中心来支持DAIT 哮喘和过敏性疾病、自身免疫性疾病和移植领域的研究。该地区 在实体器官移植方面，中心将支持4个联盟： （CTOT），儿童器官移植临床试验（CTOT-C），移植基因组学 合作研究计划（GTCRP）和免疫耐受的器官移植部分 网络（ITN）。在中心内，对这4个联盟的支持将由一个小组组织， 移植组（TG）。TG的目标是提供出色和高效的研究协调 移植研究联盟的支持服务。为了实现这一目标，RhoFED旨在（1） 提供在DAIT支持的联盟进行的移植研究方面经验丰富的工作人员，并组织 这些工作人员在一个有效管理资源的行政结构中， 研究联盟和DAIT，并促进沟通和合作;（2）提供经验丰富的 科学家和统计学家与临床研究人员和DAIT高级官员合作， 并分析移植研究的整个范围内的研究;（3）促进发展，审查， 通过专门的TG对方案和方案相关文件的初稿和后续草案进行修订 方案团队;以及（4）提供研究启动和研究管理功能， 有效和道德的研究。由于RhoFED目前是统计和临床协调部门， CTOT、CTOT-C和GTCRP联合体的统计数据协调中心（SACC） （SDCC），Rho是唯一有资格在这些联盟中提供综合中心支持的公司。 通过为工作人员提供支持移植研究的经验， 旨在加强DAIT项目官员和财团调查人员之间的合作， 为了实现灵活有效的资源管理，我们相信，通过新的 成立的中心及其TG将直接有助于实现DAIT的目标，以改善临床 实体器官移植后的结果。