Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 9926253
• 负责人: David T. Marshall
• 金额: $ 14.82万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9926253
• 关键词: Cancer Center; Cancer Center Support Grant; Catchment Area; Child; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Communication; Conceptions; Data; Data Reporting; Development; Diagnosis; Enrollment; Ensure; Fostering; Good Clinical Practice; Individual; Industrialization; Infrastructure; Institutes; Intervention; Intervention Studies; Intervention Trial; Investigational Drugs; Leadership; Learning; Malignant Neoplasms; Medical; Minority; Monitor; National Clinical Trials Network; Oncology; Patients; Pediatric Oncology; Pediatric Oncology Group; Peer Review; Performance; Policies; Procedures; Process; Progress Reports; Protocol Compliance; Protocols documentation; Publications; Quality Control; Reporting; Research; Research Personnel; Research Support; Risk; Safety; Serious Adverse Event; Services; South Carolina; Strategic Planning; Time; Training; Training and Education; United States National Institutes of Health; Universities; Woman; anticancer research; base; cancer clinical trial; data integrity; data management; data warehouse; ethnic minority population; member; minority children; oncology trial; patient population; patient safety; quality assurance; racial minority; real time monitoring; recruit; repository; research study

CLINICAL PROTOCOL & DATA MANAGEMENT: SUMMARY Part I: Clinical Protocol & Data Management (CPDM). The Clinical Trials Office (CTO) at the Medical University of South Carolina (MUSC) Hollings Cancer Center (HCC) is comprised of 65.5 FTEs who provide centralized research support services to cancer center investigators. These services include comprehensive regulatory support from protocol conception to activation, Investigational New Drug support, registration of new trials, and results reporting with ClinicalTrials.gov. The CTO also optimizes accrual to externally peer- reviewed, investigator-initiated, National Clinical Trials Network, and industrial sponsored trials by providing a centralized core of trained clinical research coordinators and data managers to cancer center investiga- tors. Research coordination and protocol compliance is enhanced through fostering of investigator-patient- CTO interaction, collaboration, and teamwork. The CTO actively assesses protocol and regulatory compli- ance and monitors data accuracy and timeliness. As the central data repository of all oncology-related trial activities, the CTO provides comprehensive reports and performance metrics to the cancer center leadership for proper oversight and strategic planning including the development of training and education initiatives for both clinical research staff and investigators and other process improvement endeavors. In 2017 alone, the CTO reported the recruitment of 1,520 individuals into all clinical research studies within the HCC (1,266 interventional and 254 non-interventional accruals) and has facilitated the activation of more than 83 studies, including 19 institutional and externally peer-reviewed studies. Part II: Data & Safety Monitoring (DSM). DSM is required for all interventional studies. For cancer center investigator-initiated studies, the center has established its own Data & Safety Monitoring Committee (DSMC), which performs risk-based monitoring to ensure the highest levels of patient safety. Effective qual- ity control functions are also instituted to ensure the highest level of protocol compliance according to the HCC’s NCI-approved Data & Safety Monitoring Plan (DSMP). In 2017, the DSMC monitored 14 studies, which included the review of 18 audits, 14 progress reports, and 70 serious adverse events. Part III: Inclusion of Women and Minorities in Research. The HCC maintains and supports multiple, proactive efforts to promote the recruitment of women and minorities. In 2017, among the 1,520 individu- als enrolled onto all studies, 50% were women and 33% represented ethnic and racial minorities. Part IV: Inclusion of Children in Research. The HCC supports the NIH policy on the inclusion of children in research. The HCC is an active member of the NCTN Children’s Oncology Group and several other na- tional pediatric oncology trial consortia. In 2017, the CTO reported the recruitment of 53 children into all clinical research studies within the HCC (22 interventional and 31 non-interventional accruals).

临床方案和数据管理：总结 第一部分：临床方案和数据管理 (CPDM)。医学部临床试验办公室 (CTO) 南卡罗来纳大学 (MUSC) 霍林斯癌症中心 (HCC) 由 65.5 名 FTE 组成，他们提供 为癌症中心研究人员提供集中研究支持服务。这些服务包括全面的 从方案构思到激活的监管支持、研究性新药支持、注册 新试验以及通过 ClinicalTrials.gov 报告结果。 CTO 还优化了外部同行的应计费用 审查、研究者发起、国家临床试验网络和工业赞助的试验，通过提供 由训练有素的临床研究协调员和数据管理人员组成的集中核心，负责癌症中心的调查 托尔。通过培养研究者-患者-研究协调和方案合规性得到加强 CTO 互动、协作和团队合作。 CTO 积极评估协议和监管合规性 并监控数据的准确性和及时性。作为所有肿瘤学相关的中央数据存储库 试验活动中，CTO 向癌症中心提供全面的报告和绩效指标 领导适当的监督和战略规划，包括发展培训和教育 临床研究人员和研究人员的举措以及其他流程改进工作。在 仅 2017 年，CTO 就报告招募了 1,520 名个人参与该项目内的所有临床研究。 HCC（1,266 例介入性应计费用和 254 例非介入性应计费用）并促进了更多 超过 83 项研究，其中包括 19 项机构研究和外部同行评审研究。 第二部分：数据和安全监控 (DSM)。所有介入研究都需要 DSM。对于癌症中心 研究者发起的研究，中心建立了自己的数据和安全监测委员会 (DSMC)，执行基于风险的监控，以确保最高水平的患者安全。有效的质量 还建立了控制功能，以确保根据协议达到最高水平的合规性 HCC 经 NCI 批准的数据和安全监测计划 (DSMP)。 2017 年，DSMC 监测了 14 项研究， 其中包括审查 18 项审计、14 份进度报告和 70 起严重不良事件。 第三部分：将妇女和少数群体纳入研究。 HCC 维护并支持多个、 积极努力促进招募妇女和少数族裔。 2017 年，在 1,520 名个人中 参加所有研究的人中，50% 是女性，33% 是少数族裔和种族。 第四部分：将儿童纳入研究。 HCC 支持 NIH 关于包容儿童的政策 在研究中。 HCC 是 NCTN 儿童肿瘤学组和其他几个国家的积极成员 国家儿科肿瘤学试验联盟。 2017 年，CTO 报告称，所有临床试验招募了 53 名儿童。 HCC 内的研究（22 项介入性研究和 31 项非介入性应计研究）。