FDA CDER Director on Benlysta for lupus and adaptive clinical trials.

July 27, 2011- Janet Woodcock, MD, Director of the FDAs new drug division, CDER, discusses with Steven Greer, MD the first drug approved to treat lupus in 50 years, Benlysta (belimumab). The BLISS trials were somewhat innovative in that the second trial was adapted to use seropositive markers to ensure that true-lupus patients were enrolled, thereby decreasing the chances of a non-responder. This led to a discussion of adaptive clinical trials that change during the enrollment after interim looks.