Clinical Protocol and Data Management

项目总结/摘要 第一部分：临床方案和数据管理（CPDM）。CPDM促进了所有临床癌症研究， 马基癌症中心（MCC），并负责增加到1,000多个干预应计费用， 在报告期内，9，357项干预性应计项目。CPDM有3个主要组成部分： 临床研究办公室（CRO）、质量保证（QA）办公室和MCC数据和安全性监测 计划（DSMP）。由临床翻译副总监Susanne Arnold（医学博士）进行监督 (DT)，负责监督CRO医学总监（Jonathan Feddock，MD [DT]）和Precision Medicine 中心（PMC）主任（Jill Kolesar，PharmD，MS [DT]），由行政副主任协助 （大卫M. Gosky，MA，MBA）。CRO由4个运营部门组成：财务、法规、临床和 精准医学，为研究者提供集中的专业知识和实施支持， 协调和执行癌症临床试验。癌症研究信息学共享资源设施 通过集中的临床试验管理和向国家癌症研究所报告来支持CRO （NCI）。CRO工作人员专注于MCC的使命、愿景和价值观，以支持最高级别的研究者 符合所有联邦和州指南的高质量临床癌症研究。 第二部分：数据和安全性监测。由MCC研究者或MCC进行的所有癌症临床试验 研究网络包括数据监督和安全监测。MCC DSMP，由NCI于 2013年，并每年修订，为所有癌症临床试验的开展提供了指导， NCI CCSG要求。数据和安全监测委员会（DSMC）确保患者安全， 在本报告所述期间，该中心监测了1 654项审判。 质量保证办公室和审计委员会对试验进行监测和审计，包括107项试验， 在本报告所述期间，并协助9次成功的外部审计。 第三部分：妇女和少数民族参与临床研究。管理协委会领导层、调查员和 工作人员致力于纳入妇女，所有少数民族和我们的国家卫生研究院指定的 阿巴拉契亚中部特殊人群的癌症临床试验。虽然许多试验有基因组，组织学或 阶段特定的入选标准，尽一切努力纳入，重点是临床试验， 少数发病率如乳腺癌（非裔美国人），肝细胞癌（西班牙裔/拉丁裔， 非裔美国人）和前列腺癌（非裔美国人）。女性占应计利润的60%以上， 2016年，有1，892名妇女接受了治疗干预，并加入了干预方案。 第四部分：临床研究中儿童的纳入。英国儿科肿瘤学和血液学分部 通过儿童肿瘤学小组和化疗药物启动的试验， 常见（白血病/淋巴瘤、神经母细胞瘤、肾母细胞瘤、骨肉瘤）至罕见儿科癌症。

PROJECT SUMMARY/ABSTRACT Part I: Clinical Protocol and Data Management (CPDM). CPDM facilitates all clinical cancer research at the Markey Cancer Center (MCC) and is responsible for an increase to over 1,000 interventional accruals per year and 9,357 interventional accruals over the reporting period. The CPDM has 3 major components: the Clinical Research Office (CRO), the Quality Assurance (QA) Office and the MCC Data and Safety Monitoring Plan (DSMP). Oversight is provided by the Associate Director for Clinical Translation, Susanne Arnold, MD (DT), who supervises the CRO Medical Director (Jonathan Feddock, MD [DT]) and the Precision Medicine Center (PMC) Director (Jill Kolesar, PharmD, MS [DT]), assisted by the Associate Director for Administration (David M. Gosky, MA, MBA). The CRO consists of 4 operational units: Finance, Regulatory, Clinical and Precision Medicine, providing investigators with centralized expertise and support for the implementation, coordination and execution of cancer clinical trials. The Cancer Research Informatics Shared Resource Facility supports the CRO through centralized clinical trials management and reporting to the National Cancer Institute (NCI). The CRO staff focuses on MCC's mission, vision and values to support investigators in the highest quality clinical cancer research with adherence to all federal and state guidelines. Part II: Data and Safety Monitoring. All cancer clinical trials conducted by MCC investigators or the MCC Research Network include oversight of data and safety monitoring. The MCC DSMP, approved by the NCI in 2013 and revised annually, provides guidance for the conduct of all cancer clinical trials in accordance with the NCI CCSG requirements. The Data and Safety Monitoring Committee (DSMC) assures patient safety and protocol compliance by MCC investigators and staff, and has monitored 1,654 trials during the reporting period. The QA Office and the Audit Committee perform monitoring and auditing of trials, including 107 trials over the reporting period, as well as assisting in 9 successful external audits. Part III: Inclusion of Women and Minorities in Clinical Research. MCC leadership, investigators and staff are committed to the inclusion of women, all minorities and our National Institutes of Health-designated special population of Central Appalachia in cancer clinical trials. While many trials have genomic, histologic or stage-specific entry criteria, every effort is made toward inclusion, with a focus on clinical trials with high minority incidence such as breast cancer (African-American), hepatocellular carcinoma (Hispanic/Latino, African-American) and prostate cancer (African-American). Females represent over 60% of accruals to treatment interventions and 1,892 women were accrued to interventional protocols in 2016. Part IV: Inclusion of Children in Clinical Research. UK's Pediatric Oncology and Hematology Division has a broad portfolio of trials via the Children's Oncology Group and investigator-initiated trials, spanning common (leukemia/lymphoma, neuroblastoma, Wilms tumor, osteosarcoma) to rare pediatric cancers.