- Planning, Execution, Analysis, and Reporting
Mark Chang · 2014
The U.S. FDA released the draft Guidance for Industry, Adaptive Design Clinical Trials for Drugs and Biologics in February 2010. Since then, more than four years has past, no updated or final version has yet been seen. Because it is a draft, it is not recommended for implementation. Adaptive design study has made big progress in the past five years and some of the FDA’s views in the draft may be out of date. Nevertheless, there is much valuable information we should be aware of, and everyone who practices adaptive trials should carefully read the draft guidance. The Journal of Biopharmaceutical Statistics published a special issue (Liu and Chang, 2010) of discussion papers on the draft adaptive design guidance by the U.S. Food and Drug Administration. In this special discussion issue, technical papers were invited not only to address existing problems with adaptive designs as pointed out by the FDA guidance but also to introduce new designs for clinical trial settings that have not been adequately tackled in the literature.