对适应性无临床试验的系统审查,用于晚期瘤发展阶段的临床试验
Kristine Broglio1, Freda Cooner2, Yujun Wu3
1AstraZeneca, Gaithersburg, MD, USA. kristine.broglio@astrazeneca.com.
Therapeutic innovation & regulatory science
|June 11, 2024
概括
无的临床试验设计将多个阶段整合到一个研究中,以提高瘤药物开发的效率和成功率. 关键考虑因素包括统计学有效性,运营执行和新型癌症疗法的监管合规性.
科学领域:
- 在瘤学瘤学.
- 临床试验设计 临床试验设计
- 药物开发 药物开发
背景情况:
- 尽管取得了进展,但瘤学面临着较低的新药成功率.
- 适应性和无的临床试验设计旨在提高效率和成功.
- 无设计将多个试验阶段结合到一个单一的研究中,以提高效率.
研究的目的:
- 审查瘤学无临床试验设计的先例.
- 分析具有确认意图的无试验的特征.
主要方法:
- 对无瘤学试验进行了全面的文献搜索.
- 使用描述性统计数据提取和分析试验设计特征.
主要成果:
- 确定了68项相关的临床试验.
- 最常见的特征:对于阶段进展的疗效门.
- 剂量/疗程选择是另一个常见的特征.
- 推断和操作无设计均有代表性.
结论:
- 无II/III期设计需要对操作特征和I型错误控制进行仔细的统计考虑.
- 诸如积累,药物供应和试验完整性等操作方面对于阶段过渡至关重要.
- 无设计非常适合现代瘤学,包括剂量选择和个性化医疗方法.
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