Children's Oncology Group Statistics and Data Center

儿童肿瘤学组统计和数据中心

• 批准号: 10473106
• 负责人: TODD A ALONZO
• 金额: $ 93.32万
• 依托单位: PUBLIC HEALTH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-01 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10473106
• 关键词: Administrative Supplement; Adolescent; Canada; Cancer Center; Childhood; Clinical Trials; Clinical Trials Cooperative Group; Country; Data; Data Set; Funding; Future; Generations; Histology; Malignant Childhood Neoplasm; Mandatory Reporting; Outcome; Patients; Pediatric Hospitals; Pediatric Oncology Group; Phase; Publications; Publishing; Research; Research Personnel; Universities; anticancer research; arm; data archive; data centers; design; improved; phase 2 study; phase 3 study; repository; secondary analysis; statistics; tumor

Administrative Supplement to Support Public Availability of Legacy COG Clinical Trial Data The NCTN/NCORP Data Archive serves as a repository of clinical trial data from phase 3 studies funded by the NCI and published after 2015. However, some clinical trials are excluded from mandatory reporting to the NCI Data Archive, including phase 1 or 2 studies and older phase 3 studies with primary publication dates prior to 2015. Some of these datasets may be useful for secondary analyses by other investigators if patient-level data were made available publicly. For example, a well annotated clinical trial dataset from phase 1 or 2 studies could be used as an external control for the purpose of FDA approval of an agent evaluated in a single arm study without a concurrent control arm. Another example is the pooling of outcome data for an uncommon tumor histology from multiple phase 2 studies to guide the design of a future study. To increase the number of study datasets that are available for public use, COG is requesting an administrative supplement to fund the generation of selected legacy clinical trial datasets.

行政补充以支持公共可用性的遗产cog临床试验 数据 NCTN/NCORP数据存档是第3阶段临床试验数据的存储库 NCI资助并在2015年之后发表的研究。但是，一些临床试验被排除在外 从强制性报告到NCI数据存档，包括1或2阶段的研究和较旧的研究 第三阶段研究与2015年之前的主要出版日期。其中一些数据集可能是 如果提供患者级数据，则对其他研究人员进行二次分析有用 公开。例如，从第1阶段或2阶段研究的注释良好的临床试验数据集可能是 用作外部控制的目的，用于FDA批准单臂评估的代理 没有并发控制臂学习。另一个例子是汇总结果数据 来自多个阶段2研究的肿瘤组织学不常见，以指导未来研究的设计。 为了增加可用于公共使用的研究数据集的数量，COG要求 为了资助所选旧版临床试验数据集的生成的行政补充。