Challenges in statistical review of clinical trials

The new 2009 ASA Biopharm newsletter is out, and the cover article is important not for the advice it gives to statistical reviewers (I'm assuming the point of view of an industry statistician), but for a glimpse into the mindset of a statistical reviewer at the FDA. Especially interesting is the use of similar results in a trial as a warning sign for potential fraud or misrepresentation of the actual data.