CLINICAL TRAILS CORE

临床试验核心

• 批准号: 7529388
• 负责人: AFSHIN DOWLATI
• 金额: $ 41.65万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-06 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7529388
• 关键词: Arts; Cancer Center; Cancer Patient; Cities; Clinical; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Cooperative Group; Core Facility; Enrollment; Goals; Health; Hospitals; Institution; Ireland; Malignant Neoplasms; Mission; Ohio; Participant; Patients; Peer Review; Pharmacologic Substance; Policies; Procedures; Process; Protocols documentation; Research; Resource Sharing; System; Therapeutic; Therapeutic Studies; Training; University Hospitals; anticancer research; authority; cancer therapy; data acquisition; performance site; programs; quality assurance; translational clinical trial

The mission of the Case CCC is to develop and support a highly collaborative and translational clinical trials program, which is fully integrated and bridges the Case CCC scientific partner institutions at UHC and CCF. The goal is to provide access for cancer patients residing in northeast Ohio to state-of-the-art clinical trials, to develop new anticancer therapies, and to contribute to the clinical science of advancing therapeutics for the cancer patient. The Clinical Trials Shared Resource, also referred to as the Clinical Trials Unit (CTU) core facility, is responsible for the registration of patients and/or participants and data acquisition for all cancer protocols, including externally peer reviewed, institutional, pharmaceutical sponsored, and cooperative group clinical trials at UHC and CCF. The CTU is part of the overall support for clinical trials research and is coordinated with the PRMS, the DSMP, and is aligned with the priorities of clinical research as outlined by program and senior leaders. The coordination functions of the CTU have been developed and redeployed to reflect the coordination of activities supporting clinical trials research at the partner institutions. These processes were approved after review by the Case CCC EAB. Under the partnership arrangement, two prominent and clinically active institutions, UHC and CCF, combine efforts in clinical trials cancer research. The responsibility of the CTU is to coordinate these activities, providing oversight for research staff training, quality assurance and audit review, developing policy and procedures for clinical trials activation, accrual and management, and having a procedure for management of disagreements and operational details. Since the CTU serves as the clinical trials research coordinating center, which is expected to expand to include oversight to other hospitals that are affiliated with Case (Metro Health and the Cleveland VA), or owned by the hospital systems of UHC or CCF (a total of 7 other affiliated institutions), the Case CCC needs to have strong centralized authority. To this end, the CTU is organized to include centralized functions within the Case CCC and distributed responsibilities that reside within the partnership hospitals, currently the Ireland Cancer Center of UHC and the Taussig Cancer Center of CCF. In 2005, a total of 3,249 patients were enrolled onto Case CCC clinical trials, including 877 therapeutic (31% of whom are registered to investigatorinitiated trials) and 2,366 non-therapeutic studies. PERFORMANCE SITE(S) (organization, city, state) University Hospitals of Clevel

案例CCC的使命是开发和支持高度协作和转化的临床试验 该计划是完全整合的，并在UHC和CCF的Case CCC科学合作伙伴机构之间架起了桥梁。 目标是为居住在俄亥俄州东北部的癌症患者提供最先进的临床试验， 开发新的抗癌疗法，并为临床科学做出贡献， 癌症患者。临床试验共享资源，也称为临床试验单元（CTU）核心 该机构负责登记患者和/或参与者以及所有癌症的数据采集 方案，包括外部同行评审、机构、制药赞助和合作小组 UHC和CCF的临床试验。CTU是临床试验研究整体支持的一部分， 与PRMS、DSMP协调，并与以下概述的临床研究优先事项保持一致： 计划和高级领导人。反恐股的协调职能已经发展和重新部署， 反映了合作机构支持临床试验研究活动的协调。这些 经Case CCC EAB审核后，流程获得批准。根据伙伴关系安排， 著名和临床活跃的机构，UHC和CCF，联合收割机在临床试验癌症研究方面的努力。 反恐组的责任是协调这些活动，监督研究人员的培训， 质量保证和审计审查，制定临床试验启动、应计和 管理，并有一个管理分歧和操作细节的程序。以来 CTU作为临床试验研究协调中心，预计将扩大到包括 对其他附属于Case（Metro Health和Cleveland VA）或由 UHC或CCF的医院系统（共7个其他附属机构），案例CCC需要具有 强大的中央集权。为此，反恐组的组织包括中央职能， 案例CCC和合作医院（目前为爱尔兰）内部的分布式责任 UHC癌症中心和CCF Taussig癌症中心。二零零五年，共有3，249名病人 入组病例CCC临床试验，包括877例治疗性（其中31%注册为治疗性启动 试验）和2，366项非治疗性研究。 履约地点（组织、城市、州） Clevel大学医院