Children's Oncology Group Statistics and Data Center

儿童肿瘤学组统计和数据中心

• 批准号: 9025428
• 负责人: TODD A ALONZO
• 金额: $ 816.76万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-15 至 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9025428
• 关键词: Adolescent; Adverse event; Australia; Biology; Cancer Center; Cancer Therapy Evaluation Program; Caring; Case Report Form; Child; Childhood; Childhood Cancer Treatment; Children' s Cancer Group; Clinical; Clinical Data; Clinical Research; Clinical Treatment; Clinical Trials; Collaborations; Companions; Data; Data Analyses; Databases; Development; Diagnosis; Enrollment; Europe; Evaluation; Factor Analysis; Finding by Cause; Florida; Goals; Human Resources; Institution; Intention; Intervention; Laboratories; Leadership; Link; Malignant Childhood Neoplasm; Malignant Neoplasms; Manuscripts; Modality; Monitor; National Clinical Trials Network; Nebraska; New Zealand; North America; Outcome; Outcome Study; Pediatric Hospitals; Pediatric Oncology; Pediatric Oncology Group; Performance; Policies; Procedures; Prognostic Factor; Protocols documentation; Publications; Quality of life; Reporting; Research; Research Personnel; Research Priority; Resources; Rhabdomyosarcoma; Safety; Site; Specific qualifier value; Specimen; Statistical Study; System; Time; United States; Universities; Update; abstracting; anticancer research; base; data management; design; experience; fight against; genomic data; member; patient subsets; prevent; statistical center; statistics; technical report

DESCRIPTION (provided by applicant): The Children's Oncology Group (COG) Statistics and Data Center (SDC), collaborates with the COG membership to design, conduct analyze and report the results of clinical trials of the treatment of childhood cancers and associated, laboratory-based, companion studies of the biology of these malignancies. Specifically, COG SDC personnel: Participate in the setting and evaluation of COG research priorities; collaborate in the development of study concepts and protocols. In particular, members of the SDC develop the study's statistical considerations; collaborate in the development and implementation of the study's case- report forms for the Group's clinical data management system; monitor study enrollment and the quality and completeness of study data submission; produce interim reports on study conduct and adverse event experience for the Group membership and protocol-specified interim analyses of study outcomes for the Group's Data and Safety Monitoring Committees; produce final reports of the study results for the Group membership; collaborate with laboratories to link specimen data and high dimensional genomics data with COG clinical and outcome data and to produce analyses of these data for publication; produce Technical Reports, detailing analyses performed for Group abstracts and manuscripts; conduct database and methodological research of relevance to the Group's research; perform CDUS and results reporting; monitor the performance of COG member institutions, producing reports for the Group's Institutional Performance monitoring Committee; provide data derived from COG studies to investigators external to the SDC in accordance with the policies and procedures of the Group; participate in National Clinical Trials Network initiatives and CTEP committees as appropriate.

描述（由申请人提供）：儿童肿瘤学组（COG）统计和数据中心（SDC）与COG成员合作设计，进行分析和报告了这些恶性生物学生物学的儿童癌症及其相关的，基于实验室的，基于实验室的，基于实验室的，基于实验室的，基于实验室的伴生研究的结果。具体而言，COG SDC人员：参与COG研究重点的设置和评估；合作研究概念和协议的发展。特别是，SDC的成员发展了研究的统计考虑；在该小组临床数据管理系统的研究案例报告的开发和实施方面合作；监视研究的入学率以及研究数据提交的质量和完整性；针对小组成员资格和协议指定的研究结果分析的研究行为和不利事件经验的临时报告，针对小组的数据和安全监控委员会进行研究结果；为小组成员提供研究结果的最终报告；与实验室合作，将标本数据和高维基因组学数据与COG临床和结果数据联系起来，并对这些数据进行分析以进行发布；产生技术报告，详细介绍了针对小组摘要和手稿进行​​的分析；对与小组研究的相关性进行数据库和方法论研究；执行CDU和结果报告；监控COG成员机构的绩效，为该集团的机构绩效监测委员会制作报告；根据该组的政策和程序，向SDC外部的研究人员提供了从COG研究中得出的数据；适当地参加国家临床试验网络计划和CTEP委员会。