CORE--CLINICAL INVESTIGATIONS

核心——临床研究

• 批准号: 6589968
• 负责人: SCOTT I BEARMAN
• 金额: $ 25.04万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-05-06 至 2003-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6589968
• 关键词: antineoplastics; biomedical facility; cancer information system; clinical trials; human subject; human therapy evaluation; neoplasm /cancer; neoplasm /cancer therapy; patient oriented research

Description: (Applicant's Description) The role of the Clinical Investigations Core (CIC) is to improve and increase clinical trials research at the University of Colorado Comprehensive Cancer Center. The Core Director is Scott Bearman, MD, and the Core Coordinator is Robin Hohsfield, RN, BSN. The Core performs a number of services to facilitate clinical trials research. These include scientific review, IRB submission, distribution of protocols to clinical sites and inclusion on the Cancer Center website; identifying and enrolling eligible patients; data collection and tissue/specimen procurement; adverse event reporting; coordination of patient treatment through the NCI Treatment Referrals Center mechanism; and maintenance of the CIC Database. In this grant period, we are requesting an increase in CIC support by 138% ($120,781($288,020). This budget increase is justified in several ways. There have been substantial increases in accrual to both therapeutic (43% increase) and cancer control (115% increase) trials since the previous competing renewal application. These increases are largely due to investigator-initiated studies. There is also a new service which the CIC provides, i.e. maintenance of a comprehensive relational database which was created entirely with institutional funds. The CIC Database supports SPORE studies and other funded projects. Furthermore, the CIC is a beta test site for the NCI?s Clinical Data Update System and is used to electronically submit data for Southwest Oncology Group and CaP CURE. In this funding period, the CIC will be creating protocol-specific front-end applications for funded studies, which will be supported, in part, through chargeback fees. New investigators, ongoing recruitments, and a dramatic increase in clinical space at Fitzsimons are expected to further increase accrual and usage of the CIC Database. Although the requested budget increase is large in terms of absolute dollars, it will only increase Cancer Center Support Grant support of the CIC budget from 3.6% to 6.9% in the first year. Moreover, due to the large increase in space, members involved in clinical trials research, our new Phase I trials program and planned recruitment, our strategic plan anticipates continued expansion of our clinical trials program.

描述：(申请者描述)临床医生的角色 研究核心(CIC)是改进和增加临床试验研究 在科罗拉多大学综合癌症中心。核心董事 斯科特·比尔曼，医学博士，核心协调员罗宾·霍斯菲尔德，RN，BSN。 该中心提供多项服务，以促进临床试验研究。 这些包括科学审查、IRB提交、将议定书分发给 癌症中心网站上的临床站点和收录；识别和 招募符合条件的患者；数据收集和组织/标本采购； 不良事件报告；通过NCI协调患者治疗 治疗转诊中心机制；以及CIC数据库的维护。在……里面 在此授权期内，我们要求将中投公司的支持增加138% (120,781美元(288,020美元)。这种预算增加在几个方面是合理的。 这两种疗法的应收额都有大幅增长(43% 增加)和癌症控制(增加115%)试验 相互竞争的续订申请。这些增长在很大程度上是由于 由研究人员发起的研究。还有一项新的服务，中投公司 提供，即维护一个全面的关系数据库，该数据库 完全由机构资金创建。CIC数据库支持孢子 研究和其他资助项目。此外，CIC是一个测试版网站 用于S临床数据更新系统，用于电子报送 西南肿瘤组和CAP治疗的数据。在这一资助期内， CIC将为基金创建特定于协议的前端应用程序 研究，这将得到部分支持，通过退还费用。新的 研究人员、正在进行的招聘以及临床空间的戏剧性增长 预计Fitzsimons将进一步增加CIC的应计费用和使用率 数据库。尽管就以下方面而言，所要求的预算增加幅度很大 绝对美元，它只会增加癌症中心支持赠款的支持 中投公司第一年的预算从3.6%降至6.9%。此外，由于 空间大幅增加，成员参与临床试验研究，我们的新 第一阶段试验计划和计划招聘，我们的战略计划预计 继续扩大我们的临床试验计划。