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.

支持前代COG临床试验公开可用性的行政补充 数据 NCTN/NCORP数据档案作为3期临床试验数据的存储库 由NCI资助并于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数据档案，包括1期或2期及更早的研究 主要出版日期在2015年之前的III期研究。其中一些数据集可能是 如果患者水平数据可用，则可用于其他研究者的次要分析 公开地例如，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批准在单组中评价的药物 另一个例子是一项研究的结果数据的汇总， 多项II期研究中的罕见肿瘤组织学，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，以资助选定的遗留临床试验数据集的生成。