Children's Oncology Group Statistics and Data Center

支持传统 COG 临床试验公开的行政补充 数据 NCTN/NCORP 数据档案库作为第 3 阶段临床试验数据的存储库 由 NCI 资助并于 2015 年之后发表的研究。但是，某些临床试验被排除在外 不再强制向 NCI 数据档案报告，包括 1 期或 2 期研究及更早的研究 主要发表日期在 2015 年之前的第 3 阶段研究。其中一些数据集可能是 如果提供患者级别的数据，则可用于其他研究人员的二次分析 公开。例如，来自 1 期或 2 期研究的注释良好的临床试验数据集可以是 用作外部对照，用于 FDA 批准在单臂中评估的药物 没有同时控制臂的研究。另一个例子是汇集结果数据 来自多项 2 期研究的罕见肿瘤组织学，以指导未来研究的设计。 为了增加可供公众使用的研究数据集的数量，COG 正在请求 行政补充，以资助生成选定的遗留临床试验数据集。

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.