ABSTRACT
The U.S. FDA released the draft Guidance for Industry, Adaptive Design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the FDA’s views in the draft may be out of date.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practices adaptive trials should carefully read the draft guidance.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.
