[ARCAD-亚洲临床试验数据的整合过程]
Hideaki Bando1, Yuriko Takeda, Toshihiro Misumi
1Dept. of Data Science, Dept. for the Promotion of Drug and Diagnostic Development, National Cancer Center Hospital East.
Gan to kagaku ryoho. Cancer & chemotherapy
|November 30, 2023
概括
该基金会的Aide et Recherche en Cancérologie Digestive (ARCAD) 数据库整合了转移性结直肠癌患者数据. 将使用安慰剂数据作为合成对照手臂来评估活性治疗.
科学领域:
- 在瘤学瘤学.
- 临床数据管理 临床数据管理
- 癌症研究 癌症研究
背景情况:
- 该基金会Aide et Recherche en Cancérologie Digestive (ARCAD) 数据库于2006年建立,收集来自欧洲和美国转移性结直肠癌试验的数据.
- 2021年启动的ARCAD-Asia倡议积极收集亚洲临床试验数据,将其集成到全球ARCAD数据库中.
研究的目的:
- 为了利用现有的安慰剂个人患者数据 (IPD) 作为合成控制臂 (SCAs).
- 为了比较从ARCAD数据库中获得的活性剂对SCAs的疗效.
- 将ARCAD数据库扩展到更多的亚洲IPD和多种癌症类型,以提供全面的全球资源.
主要方法:
- 来自59项试验的个人患者数据 (IPD) 的整合,涉及43,488名转移性结直肠癌患者.
- 亚洲临床试验数据的收集和整合到ARCAD-Asia和随后的ARCAD全球数据库中.
- 在救援线设置中使用1673名用安慰剂治疗的IPD作为潜在的合成对照武器.
主要成果:
- 建立了一个强大的集成全球数据库,包括来自欧洲,美国和亚洲的数据.
- 在ARCAD数据库中,有大量的安慰剂治疗患者适合开发合成对照手臂.
- 数据共享是在法国,美国和日本的三个国际数据中心建立的.
结论:
- ARCAD数据库为使用安慰剂IPD生成合成控制臂提供了宝贵的资源.
- 这种方法有助于在转移性结直肠癌中评估新型治疗药物.
- 持续扩展ARCAD数据库将提高其在全球癌症研究中的实用性.
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