Posted by Michael Wonder on 20 Oct 2016
Celgene skips the placebo, fails drug development 101
19 October 2016 - Celgene is not some dinky micro-cap biotech lacking the resources or knowledge to conduct a rigorous clinical trial, so omitting a placebo arm from the GED-0301 study is inexcusable.
Celgene wasted everyone's time by running a Crohn's disease study of GED-0301 without including a placebo arm.
Absent a placebo arm for comparison, the GED-0301 Crohn's data presented Tuesday (announced via press release on Monday) are largely uninterpretable.
A Celgene spokesperson did not respond to questions.
