Clinical Research

UI/MC孢子临床研究核心(CRC)的主要目标是直接翻译 研究项目与由这些项目产生的临床研究之间的联系。儿童权利委员会协调 临床试验的开发，协助患者的收益，管理和报告不良事件 并为临床试验数据提供质量控制。儿童研究中心还主办了分子流行病学 资源。CRC提供了临床研究与具体项目和核心之间的关键联系。这个 CRC由HCCC的Brian Link医学博士和MCCC的Thomas M.Habermann医学博士共同执导。其他 CRC的主要成员是方案制定协调员(PDC)、临床研究协会 (CRA)和设在两个站点的研究助理(RA)。PDC功能与PI和IRB的发展 并激活临床试验和同意书。CRA和RA协助招募患者参加试验， 安排协议测试，并与Biosecimens Core和特定研究项目合作，以 确保根据方案指南获取患者的转化性研究样本。这个 CRA和RA安排将数据输入生物统计和生物信息学核心。在上一次 在资助期间，CRC非常活跃，开发了4项临床试验，共收集了113名患者。此外, 截至2005年12月31日，分子流行病学资源积累了1331名符合条件的患者。《儿童权利公约》 在这次竞争性更新中与PIS合作开发了4个项目，并正在制定协议 项目1、2和4中概述的临床试验的开发。此外，儿童基金会将提供持续的支持 用于在项目3和开发项目中使用的分子流行病学资源，以及 预计随着它的成熟，它将成为一种越来越有价值的资源。儿童基金会会继续招募病人到 从第一个资助期开始保持活跃并跟踪已经登记的患者直到方案的4个试验 端点已相遇。儿童权利委员会还负责临床试验监测计划，这些计划已经完全 在两个地点都开发了。这些监测计划确保有适当的专业知识可供审查 患者协议，获得IRB批准，并定期审查正在进行的协议审查，以最大限度地提高 病人安全。总而言之，在第一个资助期内，儿童权利委员会一直是一项极其宝贵的资源。 它在高水平上发挥了作用，并将成为下一个供资期间非常重要的核心，以支持 临床试验研究、转化研究项目和流行病学项目。

The UI/MC SPORE Clinical Research Core (CRC) has as its primary goal to be the direct translational link between research projects and clinical research emanating from these projects. The CRC coordinates the development of clinical trials, assists in patient accrual, manages and reports adverse events to appropriate agencies, and provides quality control on clinical trial data. The CRC also hosts the Molecular Epidemiology Resource. The CRC provides a critical link between clinical research and the specific projects and cores. The CRC is co-directed by Brian Link, M.D., at the HCCC and Thomas M. Habermann, M.D., at the MCCC. Other key members of the CRC are Protocol Development Coordinators (PDC), Clinical ResearchAssociates (CRA), and Research Assistants (RA) located at both sites. The PDC functions with the PI and IRB to develop and activate the clinical trial and consent form. The CRA and RA assists in recruiting patients to the trials, schedules protocol tests, and collaborates with the Biospecimens Core and the specific research projects to ensure that translational research samples from patients are obtained according to protocol guidelines. The CRA and RA arranges for data entry into the Biostatistics and Bioinformatics Core. During the previous funding period, the CRC was very active and developed 4 clinical trials that accrued 113 patients. In addition, the Molecular Epidemiology Resource accrued 1,331 eligible patients through December 31, 2005. The CRC has worked with the Pis to develop the 4 projects in this competitive renewal and is in the process of protocol development for clinical trials outlined in Projects 1, 2, and 4. In addition, the CRC will provide ongoing support for the Molecular Epidemiology Resource that is being used in Project 3 and a developmental project, and is expected to be an increasingly valuable resource as it matures. The CRC will continue to recruit patients to the 4 trials that remain active from the first funding period and follow patients already enrolled until protocol endpoints are met. The CRC is also responsible for the clinical trials monitoring plans, which have been fully developed at both sites. These monitoring plans assure that the appropriate expertise is available to review the patient protocols, obtain IRB approval, and provide periodic review of ongoing protocol review to maximize patient safety. In summary, the CRC has been an extremely valuable resource during the first funding period. It has functioned at a high level and will be a very important core in the next funding period to support the clinical trials research, translational research projects, and epidemiology projects.