Comments on the Draft Guidance on oAdaptive Design Clinical Trials for Drugs and Biologicso of the US Food and Drug Administration
Comments on the Draft Guidance on oAdaptive Design Clinical Trials for Drugs and Biologicso of the US Food and Drug Administration
复制标题
DOI：
10.1080/10543406.2010.514453
复制
发表时间：
2010-01-01
影响因子：
1.1
通讯作者：
Wassmer, Gernot
中科院分区：
文献类型：
--
作者：
Brannath, Werner;Burger, Hans Ulrich;Wassmer, Gernot
美国FDA发布了一份关于药物和生物制品适应性设计临床试验的指南草案，该指南为计划采用适应性设计的探索性和确证性临床试验的方法学问题提供了监管指南。本评论总结了2010年春季国际生物识别学会奥地利-瑞士和德国地区的适应性设计和多重测试程序联合工作组在90天公众评论期内的讨论。
The U.S. FDA has published a draft guidance on oAdaptive Design Clinical Trials for Drugs and Biologicso, which gives regulatory guidance on methodological issues in exploratory and confirmatory clinical trials planned with an adaptive design. This comment summarizes the discussion within the joint working group oAdaptive Designs and Multiple Testing Procedureso of the Austro-Swiss and German regions of the International Biometric Society held at the 90-day public comment period in spring 2010.