PROJECT 11. Clinical Research and Data

项目 11. 临床研究和数据

• 批准号: 8740621
• 负责人: John Hayslip
• 金额: $ 13.3万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-08 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8740621
• 关键词: Accounting; Appalachian Region; Area; Cancer Center; Cancer Center Support Grant; Clinical; Clinical Data; Clinical Nursing Research; Clinical Research; Clinical Research Associate; Clinical Trials; Clinical Trials Database; Conduct Clinical Trials; Data; Databases; Development; Disadvantaged; Ensure; Epidermis; Faculty; Financial Support; Goals; Good Clinical Practice; Industry; Kentucky; Location; Maintenance; Malignant Neoplasms; Mission; Monitor; Nurses; Participant; Patients; Performance; Pharmacy facility; Phase; Physicians; Population; Procedures; Process; Protocols documentation; Quality Control; Reporting; Research; Research Activity; Research Infrastructure; Research Personnel; Research Priority; Resource Sharing; Resources; Risk; Safety; Services; Therapeutic; Time; Training; Training and Education; Translational Research; Universities; Update; anticancer research; base; data management; design; digital; experience; protocol development; quality assurance; tool

The Markey Cancer Center (MCC ) Clinical Research and Data Management Shared Resource Facility (CRDM SRF ) coordinates and facilitates clinical cancer trials at the MCC . The major goals of this shared resource are to provide support of the clinical trial process, including implementing and regulating trials, provide a centralized clinical trial database, and integrate with the following: investigational pharmacy support, financial accounting, data safety monitoring, and quality assurance. This shared resource also assists physician investigators in the design and subsequent conduct of clinical trials through its support of the Investigator Initiated Trial Protocol Development Unit . It epidermis all regulatory reporting and quality assurance needed to comply with Good Clinical Practice in the performance of clinical trials. The CRDM SR F has Standard Operating Procedures for all its activities, including training of all new faculty and staff. From Ma y 2011 through April l 2012 , 2,542 new patients with cancer were seen at the MCC . Of these, 1,451 were from Appalachia n Kentucky . During this time period, the CRDM SR F administrate d therapeutic cancer clinical trials that engaged 253 (10% ) participants in therapeutic intent clinical trials. Importantly, 141 Appalachian patients were engaged in therapeutic intent clinical research, a 10 % accrual rate from this disadvantaged and unique population.

Markey癌症中心(MCC)临床研究和数据管理共享资源设施(CRDM SRF)协调和促进MCC的临床癌症试验。这一共享资源的主要目标是为临床试验过程提供支持，包括实施和规范试验，提供一个集中的临床试验数据库，并与以下各项集成：研究药房支持、财务会计、数据安全监测和质量保证。这一共享资源还通过其对调查员发起的试验方案制定股的支持，协助内科研究人员设计和随后进行临床试验。IT Epiderm是在临床试验中遵守良好临床实践所需的所有法规报告和质量保证。CRDM SR F的所有活动都有标准操作程序，包括对所有新教职员工的培训。从2011年2月到2012年4月，L在MCC就诊了2,542名新的癌症患者。其中，1451人来自阿巴拉契亚和肯塔基州。在这段时间里，CRDM SR F进行了治疗癌症的临床试验，有253人(10%)参与了治疗意向临床试验。重要的是，141名阿巴拉契亚患者参与了治疗意向临床研究，从这一弱势和独特的人群中获得了10%的应收率。