Children's Oncology Group Statistics and Data Center

行政副刊支持传统COG临床试验向公众开放 数据 NCTN/NCORP数据档案库是3期临床试验数据的储存库 由NCI资助并在2015年后发表的研究。然而，一些临床试验被排除在外。 从强制性报告到NCI数据归档，包括第一阶段或第二阶段研究和更早的研究 第三阶段研究的初步发表日期在2015年前。其中一些数据集可能是 如果患者级别的数据可用，则对其他调查人员的二次分析很有用 公开的。例如，来自1期或2期研究的经过良好注释的临床试验数据集可以是 用于FDA批准在单个ARM中评估的药物的外部对照 在没有并发控制的情况下学习。另一个例子是将结果数据汇集在一起 来自多个2期研究的罕见肿瘤组织学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，为选定的遗留临床试验数据集的生成提供资金。

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.