在全球试验网络中协调质量改进指标,以推进儿科临床试验交付
Sabah Attar1,2, Angie Price3, Collin Hovinga4
1Department of Women's and Children's Health, Liverpool Women's NHS Foundation Trust, University of Liverpool, Crown Street, Liverpool, L8 7SS, UK. sgattar@liverpool.ac.uk.
全球合作是必要的,以加快儿科药物的批准. 这项研究比较了三个儿科网络的指标,发现差异突出了统一,可互操作的方法改善临床试验的机会.
科学领域:
- 临床药理学 临床药理学
- 儿科研究中的儿科研究
- 医疗服务研究 医疗服务研究
背景情况:
- 尽管持续努力,儿童药物批准在全球范围内面临重大延迟.
- 网络间的协作对于克服这些挑战至关重要.
- 这项研究启动了通过比较临床试验行为指标来加强儿科网络之间的互操作性.
研究的目的:
- 为了比较临床试验的驱动因素和内容,进行三个不同的儿科网络使用的指标.
- 为了识别标准开发方法的共同点和差异.
- 为开发跨网络共享,可互操作的指标奠定基础.
主要方法:
- 检查了三个儿科网络的度量识别方法:儿童高级临床试验研究所,母婴儿童和青少年研究网络和connect4children.
- 描述了每个网络开发的特定指标.
- 映射了指标一致性,以确定核心,可共享的指标.
主要成果:
- 衡量标准选择的驱动因素各不相同:网站质量改进 (11 项衡量标准),网络性能 (13 项衡量标准),或两者 (5 项衡量标准).
- 关键指标领域包括研究能力,现场可行性,试验启动和招聘.
- 确定了试验启动和进行的15个核心指标,现场批准是所有网络的共同主题.
结论:
- 儿科网络使用的驱动因素,方法和特定指标存在显著差异.
- 解决这些差异对于加快儿科药物批准的统一方法至关重要.
- 这些发现支持全球合作努力,为儿科临床试验定义可互操作的指标.
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