Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10377479
• 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
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10377479
• 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; Minority Health Research; 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 repository; ethnic minority; 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）。医学临床试验办公室（CTO） 南卡罗来纳州大学（MUSC）霍林斯癌症中心（HCC）由65.5名全职员工组成，他们提供 为癌症中心的研究人员提供集中的研究支持服务。这些服务包括： 从方案构思到启动的监管支持，研究性新药支持， 新的试验，并通过ClinicalTrials.gov报告结果。CTO还优化了外部同行的应计费用， 审查，制药商发起的，国家临床试验网络，和工业赞助的试验，通过提供 一个由经过培训的临床研究协调员和数据管理员组成的中央核心， tors.研究协调和方案依从性通过促进患者-患者- CTO互动、协作和团队合作。CTO积极评估方案和法规遵从性， 检查和监控数据的准确性和及时性。作为所有与肿瘤学相关的 试验活动，CTO向癌症中心提供全面的报告和性能指标 领导适当的监督和战略规划，包括培训和教育的发展 临床研究人员和研究者的倡议以及其他过程改进努力。在 仅在2017年，CTO就报告了1，520人参与所有临床研究， HCC（1，266例介入性和254例非介入性应计费用），并促进了更多 超过83项研究，包括19项机构和外部同行评审研究。 第二部分：数据和安全监测（DSM）。所有干预性研究都需要DSM。癌症中心 该中心已经建立了自己的数据和安全监测委员会 （DSMC），执行基于风险的监测，以确保最高水平的患者安全。有效质量- 还建立了城市控制功能，以确保最高水平的协议符合性， HCC的NCI批准的数据和安全性监测计划（DSMP）。2017年，DSMC监测了14项研究， 其中包括对18项稽查、14份进度报告和70起严重不良事件的审查。 第三部分：妇女和少数民族参与研究。HCC维护和支持多个， 积极努力促进征聘妇女和少数族裔。2017年，在1,520名个人中， 参加所有研究的ALS患者中，50%为女性，33%为少数民族和种族。 第四部分：将儿童纳入研究。HCC支持NIH关于纳入儿童的政策 在研究中。HCC是NCTN儿童肿瘤组和其他几个非肿瘤组织的活跃成员。 儿科肿瘤试验联盟。2017年，CTO报告称，招募了53名儿童进入所有临床 HCC内的研究性研究（22项干预性和31项非干预性累积）。