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中文摘要
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项目摘要/摘要-移植小组 通过这一资助机会的宣布,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金整合到一个 单一、多组件合作协议,以降低成本和提高效率 研究联盟之间的标准化。这一新计划将为支持DAIT的单个中心提供资金 在哮喘和过敏性疾病、自身免疫性疾病和移植领域的研究。在该地区 在实体器官移植方面,该中心将支持4个财团:器官移植的临床试验 (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)和免疫耐受中的器官移植部分 网络(ITN)。在该中心内,对这4个联合体的支持将组织在1个小组下,即 移植组(TG)。TG的目标是提供优秀和高效的研究协调 整个移植研究联盟的支持服务。为了实现这一目标,RhoFED的目标是(1) 提供在DAIT支持的财团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,能够响应 研究联合体和DAIT,促进沟通和协作;(2)提供经验丰富的 科学家和统计学家,他们与临床研究人员和高级DAIT官员合作,将设计 并分析移植研究的全部范围;(3)促进开发、审查、 以及通过专门的技术工作组修订议定书和与议定书有关的文件的初稿和后续草案 礼宾团队;以及(4)提供研究启动和研究管理职能,这是 高效、合乎道德地进行研究。因为RhoFED目前是统计和临床的协调 CTOT、CTOT-C和GTCRP联合体的中心(SACCC),是统计数据协调中心 (SDCC)对于ITN,RHO是唯一有资格在这些联合体中提供整合中心支持的机构。 通过为员工提供支持移植研究的经验,这是一个管理基础设施 旨在加强DAIT项目官员和财团调查人员之间的合作,并制定一项计划 对于灵活和有效的资源管理,我们相信这些财团通过新的 已形成的中心及其TG将直接促进改善临床的DAIT目标的实现 实体器官移植后的结果。
英文摘要
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.
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