Amgen's clinical trial backlash

Participants in a terminated study of Amgen Inc.'s glial-derived neurotrophic factor are suing the company in an effort to force AMGN to continue providing the unapproved experimental treatment. While the circumstances in the case are unusual because GDNF is delivered using a highly invasive technique, it could have broader implications for sponsors of drug trials.

At a minimum, the case is likely to cause sponsors to more closely scrutinize informed consent procedures, attorneys who specialize in legal issues associated with clinical trials told BioCentury...