在生物等价性研究中的中间分析的绩效评估
Naoki Isogawa1, Andy Grieve2, Ryota Ishii3
1UCB Japan Co., Ltd., Shinjuku-ku, Japan. Naoki.Isogawa@ucb.com.
Therapeutic innovation & regulatory science
|May 24, 2024
概括
对于日本的生物等价性研究,组序列设计比适应性设计更受青. 这两种方法在模拟中表现相似,但组序列设计不那么复杂.
科学领域:
- 药理动力学和药物开发
- 临床试验设计 临床试验设计
- 监管科学 监管科学
背景情况:
- 日本的生物等价性指导方针要求进行单一的关键研究.
- 由于资源的限制,临床试验的最大参与者数量往往受到限制.
- 临时分析允许在资源限制范围内进行早期生物等价性评估.
研究的目的:
- 为了比较组序列和适应性设计的性能,在中间分析中对生物等价性评估进行评估.
- 为了确定在资源限制下对日本生物等价性研究的最佳试验设计.
- 为了评估考虑预先定义的最大参与者数量的设计.
主要方法:
- 进行了一项模拟研究,以比较组序列和自适应设计.
- 该比较侧重于具有预先定义的最大参与者数量的试验.
- 使用了Pocock类型的alpha支出函数,因为预计在中间分析时会有生物等价性.
主要成果:
- 两组顺序和自适应设计在使用Pocock类型的alpha支出函数时都表现出类似的性能.
- 模拟结果表明,在特定条件下,这两种设计类型的有效性相似.
- 在进行的模拟中,在两种方法之间没有发现显著的性能差异.
结论:
- 组序列设计在日本的生物等价性研究中是可取的,因为与适应性设计相比,它们的统计和操作复杂性较低.
- 尽管模拟性能相似,但实际实施更倾向于组序列方法.
- 这些发现支持采用组序列设计,在资源有限的情况下,在日本进行高效的生物等价性评估.
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