Seamless phase II/III/IIIb clinical trial designs with different endpoints for different phases
Seamless phase II/III/IIIb clinical trial designs with different endpoints for different phases
复制标题
DOI：
10.1080/03610926.2019.1618871
复制
发表时间：
2019-05-27
影响因子：
0.8
通讯作者：
Zhao, Peng-Liang
中科院分区：
文献类型：
--
作者：
Quan, Hui;Luo, Xiaodong;Zhao, Peng-Liang
在一项无缝II/III/IIIb期试验中，K （K >= 2）剂量与安慰剂对照在II期进行了评估。根据II期结果，将选择一种剂量用于III期和IIIb期。预先指定的额外患者数量将在III期和IIIb期纳入选定剂量和安慰剂控制。III期终点的结果可能提交早期新药申请。将对选定剂量在III期和IIIb期终点的治疗效果的最终声明进行最终分析。对总体I型错误率控制执行多重调整。
In a seamless phase II/III/IIIb trial, K (K >= 2) doses versus placebo control are evaluated at phase II. Based on phase II results, one dose will be selected for phases III and IIIb. Pre-specified additional numbers of patients will be enrolled into the selected dose and placebo control during phases III and IIIb. Results of the phase III endpoint may be submitted for an early New Drug Application. Final analyses will be conducted for ultimate claims of treatment effects for the selected dose on the phase III and IIIb endpoints. Multiplicity adjustment is performed for the overall type I error rate control.