Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10116332
• 负责人: Elizabeth Fox
• 金额: $ 47.09万
• 依托单位: ST. JUDE CHILDREN'S RESEARCH HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-04-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10116332
• 关键词: Attention; Cancer Center Support Grant; Categories; Clinical; Clinical Cancer Center; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical trial protocol document; Comprehensive Cancer Center; Conceptions; Conduct Clinical Trials; Data; Development; Devices; Enrollment; Ensure; Fostering; Funding; Goals; Individual; Industrialization; Infrastructure; Institution; Intervention; Intervention Studies; Investigational New Drug Application; Life Cycle Stages; Location; Longevity; Malignant Childhood Neoplasm; Malignant Neoplasms; Monitor; Multi-Institutional Clinical Trial; Office Management; Participant; Peer Review; Performance; Personal Satisfaction; Process; Protocols documentation; Quality Control; Recommendation; Regulation; Reporting; Research Personnel; Resources; Review Committee; Risk; Safety; Saint Jude Children' s Research Hospital; Services; Standardization; System; Therapeutic; Therapeutic Intervention; Therapeutic Trials; Time; Training and Education; anticancer research; cancer clinical trial; data integrity; data management; high risk; investigator-initiated trial; member; participant enrollment; participant safety; pediatric patients; phase III trial; programs; prospective; safety study; trend; welfare

ABSTRACT – Clinical Protocol and Data Management The Central Protocol and Data Monitoring Office (CPDMO) within the St. Jude Comprehensive Cancer Center (SJCCC) provides centralized administrative, regulatory, and educational services for clinical trials-related activities. It is the coordinating center for protocol standardization, regulatory and compliance guidance, administrative submissions, protocol registration data, and monitoring. The CPDMO is integral to the Clinical Trials Administration (CTA), which provides comprehensive infrastructure for conducting SJCCC clinical trials. Together, the CTA and CPDMO perform the following functions to provide outstanding clinical trials support to SJCCC members: (1) Facilitate the development of high-quality clinical trials, within a standardized framework, to meet institutional and federal requirements. (2) Maintain a centralized submission process for institutional review and approval. (3) Set standards by fostering consistent conduct and compliance through the monitoring of all clinical trials. (4) Ensure appropriate participant enrollment via a centralized clinical trials registration system. (5) Provide infrastructure and coordinate trials at affiliate and collaborating institutions. (6) Adhere to the Data Safety Monitoring Plan, which was revised and approved by the NCI in August 2017. The CPDMO also provides administrative support to the Clinical Trials Scientific Review Committee to ensure the thorough scientific review of all trials in the SJCCC. Studies are monitored commensurate with the degree of risk to participants and the size and complexity of the study. The SJCCC's Data Safety Monitoring Board is composed of external experts who independently oversee institutional Phase III trials and high-risk trials; an Internal Monitoring Committee assesses findings from individual audit reports and safety trends and recommends educational and corrective actions. Trial monitoring and safety reporting is the responsibility of all members of the clinical trial process. Particular attention is paid to monitoring investigator-initiated trials (IITs), especially those with no external monitoring program. The CPDMO presently includes 42 staff members. Over the current funding period, the number of new pediatric patients with cancer increased 11%, from 459 in FY 2013 to 516 in FY2017: 60% enrolled into interventional therapeutic trials, and 90% of those were in institutional IITs. Similarly, the CPDMO assisted with 5,470 enrollments into interventional (therapeutic and nontherapeutic) trials, a 23% increase in accrual into this category, compared to the previous funding period. In addition, we assisted with 30,071 enrollments into non-interventional clinical trials. During the current funding period, the CPDMO managed more than 406 prospective trials, of which 52% are institutional IITs. During FY2017, the CPDMO's portfolio, subdivided by sponsor, included 61% IIT/peer reviewed, 32% national alliance/consortia, and 7% industrial. The SJCCC supported 30 investigational new drug applications and new device exemptions for 36 IITs. Presently, the CPDMO supports 116 active multisite IITs. The CPDMO is committed to serving all SJCCC members by supporting the efficient and effective conduct of high-quality translational and clinical pediatric cancer research.

摘要 – 临床方案和数据管理 圣裘德综合癌症中心内的中央方案和数据监测办公室 (CPDMO) (SJCCC) 为临床试验相关提供集中管理、监管和教育服务 活动。它是协议标准化、监管和合规指导的协调中心， 行政提交、协议注册数据和监控。 CPDMO 是临床的一部分 试验管理 (CTA)，为开展 SJCCC 临床试验提供全面的基础设施。 CTA 和 CPDMO 共同履行以下职能，为临床试验提供出色的支持： SJCCC 成员： (1) 在标准化框架内促进高质量临床试验的开展， 以满足机构和联邦的要求。 （二）保持机构集中提交流程 审查和批准。 (3) 通过监控促进一致的行​​为和合规性来制定标准 所有临床试验。 (4) 通过集中临床试验注册确保适当的参与者入组 系统。 (5) 提供基础设施并协调附属机构和合作机构的试验。 (6) 遵守 《数据安全监测计划》，国家癌症研究所于2017年8月修订并批准。CPDMO还 为临床试验科学审查委员会提供行政支持，以确保彻底的 对 SJCCC 的所有试验进行科学审查。研究的监测与风险程度相称 参与者以及研究的规模和复杂性。 SJCCC数据安全监察委员会由以下人员组成 独立监督机构 III 期试验和高风险试验的外部专家；内部 监察委员会评估个别审计报告的结果和安全趋势并提出建议 教育和纠正措施。试验监控和安全报告是所有成员的责任 临床试验过程。特别注意监测研究者发起的试验（IIT），特别是 那些没有外部监测计划的人。 CPDMO 目前有 42 名工作人员。超过电流 资助期间，新发儿科癌症患者数量增加了 11%，从 2013 财年的 459 人增加到 2013 财年的 516 人。 2017 财年：60% 参加了介入治疗试验，其中 90% 在机构 IIT 中。相似地， CPDMO 协助 5,470 名患者入组介入性（治疗性和非治疗性）试验，占 23% 与上一个供资期间相比，这一类别的应计费用有所增加。此外，我们还协助 30,071 名患者参加了非介入性临床试验。在当前资助期内，CPDMO 管理 超过 406 项前瞻性试验，其中 52% 是机构 IIT。 2017 财年期间，CPDMO 的投资组合， 按赞助商细分，包括 61% IIT/同行评审、32% 国家联盟/财团和 7% 工业。这 SJCCC 支持 30 个新药研究申请和 36 个 IIT 的新器械豁免。目前， CPDMO 支持 116 个活动的多站点 IIT。 CPDMO致力于为所有SJCCC会员提供服务 支持高效、有效地进行高质量的转化和临床儿科癌症研究。