Clinical Protocol and Data Management

临床方案和数据管理(CPDM) 摘要 临床方案和数据管理(CPDM)由加州大学洛杉矶分校医学博士(STT)Dennis Slamon领导 综合癌症中心(JCCC)临床/转译研究副主任。CPDM函数 完全驻留在JCCC临床研究部(CRU)内，由JCCC主任Michael直接授权 泰特尔，医学博士(CMINT)。CRU的总体目标及其具体目标是确保获得 在整个JCCC集水区、洛杉矶县(LAC)和 不仅如此，为了促进临床/转化肿瘤学的科学，并提供FDA批准的新的有效的 广泛使用的治疗方法。CRU提供了必要的基础设施，以执行重要和有影响力的 临床/转化性研究。JCCC主任和加州大学洛杉矶分校研究领导之间的牢固关系 使该中心能够建立肿瘤学研究的最高标准。由梅根·布伦南领导的CRU， RN，MSN，ONP，PhD，JCCC肿瘤学临床研究高级主任，为加州大学洛杉矶分校/JCCC所有教职员工服务 开展与癌症相关的临床研究。240名工作人员为60多名校长提供支持 作为调查人员，CRU每年监督和管理500多项干预试验。CRU有 为制定协议、向联邦和机构实体提交法规提供集中支持职能， 研究激活和执行、数据和安全报告、监控、审计和法规遵从性。这个 JCCC，通过数据和安全监测委员会(DSMB)和CRU监管合规办公室 (ORC)，为干预性机构试验提供监督、数据和安全性评估。JCCC确保 所有临床试验设计都是科学完整的，具有临床和科学相关性，涉及安全性 问题，以及根据州、联邦和机构政策的表现。此外，JCCC 将这些标准应用于来自内部和外部赞助商的所有临床研究。 在泰特尔的领导下，JCCC临床/转化科学和CRU已经成长并经历了变革 在短时间内发生变化。泰特尔与斯拉蒙和布伦南一起工作，迅速发现了挑战，并 潜在的新机会影响审判的应计业绩和纳入。马上，泰特尔 获得约180万美元的额外机构资金，以开发和支持新的包容性倡议、更新和 加强CRU基础设施，为JCCC成员增加更多集中化计划。在下一个项目中 在此期间，扩大了JCCC临床研究活动，重点是妇女的纳入和收益， 拉丁美洲和加勒比及其他地区的少数族裔、儿童和未得到充分服务的人口是布伦南和 斯拉蒙。JCCC在更全面的包容计划上投入了大量资金，通过四个新的 其集水区的多样性倡议，包括伯班克妇科肿瘤学倡议、Van Nuys 乳腺癌项目、橄榄园医疗中心(OVMC)项目和米勒儿童和妇女项目 医院长滩伙伴关系。

CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) ABSTRACT Clinical Protocol and Data Management (CPDM) is led by Dennis Slamon, MD, PhD (STT), UCLA Jonsson Comprehensive Cancer Center (JCCC) Associate Director for Clinical/Translational Research. CPDM functions reside fully within the JCCC Clinical Research Unit (CRU) under the direct authority of JCCC Director, Michael Teitell, MD, PhD (CMINT). The overarching objective of the CRU and its specific goals are to ensure access to clinical trials for oncology patients throughout the JCCC catchment area, Los Angeles County (LAC), and beyond, to further the science of clinical/translational oncology, and to provide new and effective FDA-approved therapies for widespread use. The CRU provides the necessary infrastructure to execute important and impactful clinical/translational studies. A strong relationship between the JCCC Director and UCLA research leadership enables the Center to establish the highest standards for oncology research. The CRU, led by Meghan Brennan, RN, MSN, ONP, PhD, JCCC Senior Director for Oncology Clinical Research, serves all UCLA/JCCC faculty conducting cancer-related clinical research. With 240 staff members supporting more than 60 principal investigators, the CRU oversees and manages more than 500 interventional trials annually. The CRU has centralized support functions for protocol development, regulatory submission to federal and institutional entities, study activation and execution, data and safety reporting, monitoring, auditing, and regulatory compliance. The JCCC, through the Data and Safety Monitoring Board (DSMB) and the CRU Office of Regulatory Compliance (ORC), provides oversight, data, and safety evaluations for interventional institutional trials. The JCCC ensures that all clinical trials design is with scientific integrity, having clinical and scientific relevance, addressing safety issues, and with performance according to state, federal, and institutional policies. Furthermore, the JCCC applies these standards to all clinical research, from both internal and external sponsors. Under Teitell, JCCC clinical/translational science and the CRU have grown and undergone transformational changes in a short period. Working together with Slamon and Brennan, Teitell quickly identified challenges and the potential for new opportunities influencing trial accrual performance and inclusion. Immediately, Teitell secured ~$1.8 M in additional institutional funding to develop and support new inclusion initiatives, update and augment the CRU infrastructure, and add more centralized programs for JCCC members. In the next project period, the expansion of JCCC clinical research activity with a focus on inclusion and accrual of women, minorities, children, and underserved populations in LAC and beyond are the highest priorities for Brennan and Slamon. The JCCC has invested substantially in a more comprehensive inclusion program through four new diversity initiatives in its catchment area, including the Burbank Gynecology Oncology Initiative, the Van Nuys Breast Cancer Program, the Olive View Medical Center (OVMC) Program, and Miller Children’s and Women’s Hospital Long Beach Partnership.