PROJECT 11. Clinical Research and Data

马基癌症中心（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，提供集中的临床试验数据库，并与以下方面相结合：研究药物支持，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者发起的试验方案制定单位的支持，协助医生研究者设计和随后进行临床试验。它涵盖了在临床试验中遵守药物临床试验质量管理规范所需的所有监管报告和质量保证。CRDM SR F为其所有活动制定了标准操作程序，包括所有新教师和工作人员的培训。从2011年5月至2012年4月1日，MCC共发现2，542例新发癌症患者。其中，1,451人来自肯塔基州的阿巴拉契亚。在此期间，CRDM SR F开展了治疗性癌症临床试验，253例（10%）受试者参与了治疗性临床试验。重要的是，141名阿巴拉契亚患者参与了治疗意图的临床研究，从这个弱势和独特的人群中获得了10%的增加率。

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.