ABSTRACT
The US FDA released the draft Guidance for Industry, Adaptive Design Clin-
ical Trials for Drugs and Biologics in February 2010. Since then, more than
four years have passed, and no updated or final version has been seen yet.
Because it is a draft, it is not recommended for implementation. Adaptive de-
sign 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views in the draft may be out of date.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 of which we should be aware and everyone who practices adaptive
trials should carefully read the draft guidance. The Journal of Biopharmaceu-
tical Statistics published a special issue (Liu and Chang, 2010) of discussion
papers on the draft adaptive design guidance. In this special discussion issue,
technical papers are invited not only to address existing problems with adap-
tive 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.
