Adaptive Randomization for Clinical Trials

In February 2010, the U.S. Food and Drug Administration (FDA, 2010 Food and Drug Administration . ( 2010 ). Guidance for Industry. Adaptive Design Clinical Trials for Drugs and Biologics (draft document). Available at www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf [Google Scholar]) 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.