ECLIM-SEHOP:如何开发一个平台,对儿童癌症进行学术试验
Antonio Juan-Ribelles1, Francisco Bautista2, Adela Cañete1
1Pediatric Oncology and Hematology Unit, Hospital Universitari y Politécnic La Fe, Instituto de Investigación Sanitaria La Fe (IISLAFE), Valencia, Spain.
概括
ECLIM-SEHOP平台加强了西班牙在国际儿科瘤学试验中的参与,支持47项研究和5250名患者. 虽然改善了访问和集中资源,但试验设置时间需要进一步优化以获得更好的结果.
科学领域:
- 儿科瘤学 儿科瘤学
- 临床试验 临床试验
- 医疗保健服务研究 医疗服务研究
背景情况:
- 成立于2017年的ECLIM-SEHOP平台旨在将西班牙儿科瘤学纳入国际合作研究中.
- 它的目标是为西班牙参与全球学术临床试验,观察性研究和注册的基础设施.
研究的目的:
- 描述ECLIM-SEHOP平台自成立以来的活动和影响.
- 分析平台支持的研究的范围和结果.
主要方法:
- 从平台的数据库中提取完全或部分支持的研究数据.
- 从2017年到2023年11月对试验招聘和设置/行为指标的分析.
主要成果:
- 支持了47项研究 (29项试验,18项观察/注册) 涉及5250名患者.
- 综合支持提供了25项研究 (16项试验,9项观察/注册).
- 平均时间:12.2个月 (规范性提交给第一个患者) 和31.3个月 (国际到西班牙网站开放).
结论:
- 在西班牙,ECLIM-SEHOP平台显著改善了对国际儿科瘤学临床试验的访问.
- 它促进了资源集中,并有助于使生存率与其他欧洲国家相提并论.
- 需要进一步改进临床试验设置时间表.
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