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，并集成以下功能：研究性药学支持、财务会计、数据安全监控和质量保证。这一共享资源还通过对研究者发起的试验方案开发单位的支持，在临床试验的设计和后续实施方面协助医师研究者。在临床试验中，所有监管报告和质量保证都需要符合良好临床实践。CRDM SR F对其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5月到2012年4月1日，在MCC发现了2542名新的癌症患者。其中，1451人来自肯塔基州的阿巴拉契亚。在此期间，CRDM SR F管理了治疗性癌症临床试验，有253名（10%）参与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向临床研究，这一弱势和独特人群的累计率为10%。

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.