Clinical Protocol and Data Management

项目总结/摘要 Markey癌症中心（MCC）临床方案和数据管理（CPDM）促进所有临床 肯塔基州大学的癌症研究。CPDM的具体目标是：1）提供全面的， 对MCC临床研究活动的集中支持; 2）确保所有研究的安全性、合规性和质量 在该中心和MCC的研究网络（MCCRN）进行的临床癌症研究，根据 数据安全和监控计划以及NCI要求; 3）整合癌症中心的所有努力， 为MCC的患者提供临床试验，包括妇女、少数民族、服务不足的人群， 4）为CPDM提供持续的教育和培训服务， MCCRN的工作人员和教师，提高团队的质量，多样性，一致性和效率，并导致 增加与MCC集水区人口的接触。CPDM通过以下方式促进临床研究 临床研究办公室的四个部门（72名全职员工）、方案开发团队（10名全职员工）、质量保证团队（1名全职员工） 计划（5 FTE）和MCCRN（11 FTE），为开发，协调， 和执行审判。2022年，临床研究办公室管理369项活跃试验-211项合作 组，113例行业申办，45例药物启动（12例研究性新药启动）。mcc的 全州范围的基础设施支持研究转诊和集水区内的应计费用。正如CPDM所做的那样， 成熟后，该中心增加了临床研究参与肯塔基州的120个县中的98个，总数为18753 应计费用（8，857例干预性; 9，896例非干预性，2018 - 2022年）。质量保证计划和 审计委员会独立于CPDM的其他组成部分运作，以支持教育、安全和 审判质量。所有癌症试验都由MCC的数据和安全监测计划指导，该计划提供 根据NCI CCSG要求进行监督。数据和安全监测委员会确保 工作人员和研究者的患者安全和方案依从性。管理协委会领导人、调查员和工作人员 将妇女、少数民族和肯塔基州的特殊人群阿巴拉契亚纳入临床癌症研究 女性的参与具有影响力（占所有干预性增加的77%，2018 - 2022年）和阿巴拉契亚 立陶宛人（61%）。加强努力增加了少数患者的试验参与，以反映该患者 人口，重点是重要的癌症差异，如肺癌和前列腺癌。支持NIH MCC致力于将整个生命周期的个体纳入临床研究。2021年，40%的 治疗性试验累计为65岁或以上的成年人，超过了全国平均水平。儿童癌症护理 由该州两个综合儿科肿瘤学项目之一提供。MCC是世界上第一个 在分子肿瘤委员会的支持下，该地区将为所有儿科肿瘤患者提供生殖细胞检测 结果的解释。

PROJECT SUMMARY/ABSTRACT The Markey Cancer Center (MCC) Clinical Protocol and Data Management (CPDM) facilitates all clinical cancer research at the University of Kentucky. CPDM’s Specific Aims are: 1) To provide comprehensive, centralized support for MCC clinical research activities; 2) To ensure the safety, compliance, and quality of all clinical cancer research performed at the center and MCC’s Research Network (MCCRN), in accordance with the Data Safety and Monitoring Plan and NCI requirements; 3) To integrate all efforts of the Cancer Center to provide clinical trial access to MCC’s patients, including women, minorities, underserved populations, and individuals across the lifespan; and 4) To provide ongoing education and training services for CPDM and MCCRN staff and faculty that enhance quality, diversity, consistency, and efficiency of teams and lead to increased engagement with MCC’s catchment population. The CPDM facilitates clinical research through the Clinical Research Office’s four units (72 FTEs), Protocol Development Teams (10 FTE), a Quality Assurance Program (5 FTE) and MCCRN (11 FTE), which provide centralized expertise for development, coordination, and execution of trials. In 2022, the Clinical Research Office managed 369 active trials—211 cooperative group, 113 industry sponsored, and 45 investigator-initiated (12 investigational new drug-enabling). MCC’s statewide infrastructure supports research referral and accrual within the catchment area. As the CPDM has matured, the center increased clinical research engagement to 98 of Kentucky’s 120 counties, with 18,753 total accruals (8,857 interventional; 9,896 non-interventional, 2018-2022). The Quality Assurance Program and Audit Committee function independently from other CPDM components to support education, safety and quality of trial conduct. All cancer trials are guided by MCC’s Data and Safety Monitoring Plan, which provides oversight in accordance with NCI CCSG requirements. The Data and Safety Monitoring Committee ensures patient safety and protocol compliance by staff and investigators. MCC leaders, investigators and staff promote the inclusion of women, minorities and Kentucky’s special population of Appalachia in clinical cancer research with impactful engagement of females (77% of all interventional accrual, 2018-2022) and Appalachian Kentuckians (61%). Enhanced efforts have increased minority trial participation to reflect this patient population, focusing on important cancer disparities such as lung and prostate cancers. In support of NIH policies, MCC strives for inclusion of individuals across the lifespan in clinical research. In 2021, 40% of therapeutic trial accruals were adults 65 or older, surpassing national averages. Cancer care for children is provided by one of two comprehensive pediatric oncology programs in the state. MCC is the first center in the region to offer germline testing to all pediatric oncology patients, supported by the Molecular Tumor Board interpretation of results.