PROJECT 11. Clinical Research and Data

：马基癌症中心L临床研究和数据管理共享资源设施(CRD M SRF)协调和促进MCC的临床癌症试验。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L数据库，并与以下内容集成：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研究员发起的试验方案制定股的支持，帮助S内科研究人员设计和随后进行L临床试验。它执行所有必要的监管报告和质量保证，以符合临床试验执行中的良好临床实践。CRDM SRF的所有活动都有标准操作程序，包括对所有新教师和工作人员的培训。从2011年1月到2012年4月，2542名新的癌症患者S在MCC就诊。其中1451人来自阿巴拉契亚肯塔基州。在S期间，CRDM SRF实施了治疗性癌症临床试验L试验，有253名(10%)的参与者参与了治疗意向临床试验。重要的是，141名阿巴拉契亚患者S参与了治疗意向临床研究，从这些不利和独特的方面获得了10%的收益。

: The Markey Cancer Center (MCC ) Clinical l Research and Data a Management Shared Resource Facility (CRD M SRF ) coordinates and facilitates clinical cancer trials at the MCC . The major goals of the shared resource are to provide support of the clinical trial process , including implementing and regulating trials provide a centralized clinical trial l database , and integrate with the following: investigational pharmacy support , financial accounting , data safety monitoring , and quality assurance . This shared resource also assist s physician investigators in the design and subsequent conduct of clinical l trials through its support of the Investigator Initiated Trial Protocol Development Unit . It performs all regulatory reporting and quality assurance needed to comply with Good Clinical Practice in the performance of clinical trials . The CRDM SRF has Standard Operating Procedures for all its activities including training of all new faculty an d staff . From Ma y 2011 through April 2012 , 2,54 2 new patient s with cancer were seen at the MCC . Of these , 1,45 1 were from Appalachian Kentucky . During the s time period , the CRDM SRF administrated therapeutic cancer clinical l trials that engage d 25 3 (10% ) participants in therapeutic intent clinical trials . Importantly , 14 1 Appalachian patient s were engage d in therapeutic intent clinical research , a 10 % accrual rate from these disadvantaged and unique.