Rosenberger William F, Sverdlov Oleksandr, Hu Feifang
Department of Statistics, George Mason University, VA 22030, USA.
J Biopharm Stat. 2012;22(4):719-36. doi: 10.1080/10543406.2012.676535.
In February 2010, the U.S. Food and Drug Administration (FDA, 2010 ) drafted guidance that discusses the statistical, clinical, and regulatory aspects of various adaptive designs for clinical trials. An important class of adaptive designs is adaptive randomization, which is considered very briefly in subsection VI.B of the guidance. The objective of this paper is to review several important new classes of adaptive randomization procedures and convey information on the recent developments in the literature on this topic. Much of this literature has been focused on the development of methodology to address past criticisms and concerns that have hindered the broader use of adaptive randomization. We conclude that adaptive randomization is a very broad area of experimental design that has important application in modern clinical trials.
2010年2月，美国食品药品监督管理局（FDA，2010）起草了一份指南，讨论了临床试验中各种适应性设计的统计学、临床和监管方面。适应性设计的一个重要类别是适应性随机化，该指南的第六部分B小节对其进行了简要讨论。本文的目的是回顾几类重要的新型适应性随机化程序，并传达有关该主题文献最新进展的信息。这些文献大多集中在方法学的开发上，以解决过去阻碍适应性随机化更广泛应用的批评和担忧。我们得出结论，适应性随机化是实验设计中一个非常广泛的领域，在现代临床试验中具有重要应用。
