BioCentury
ARTICLE | Politics & Policy

CDER's Temple wants more CER trials for symptomatic treatments

January 30, 2013 2:27 AM UTC

Robert Temple, deputy center director for clinical science at FDA's Center for Drug Evaluation and Research, said he "would like to see more" comparative effectiveness trials for symptomatic treatments to help identify potential responders. In particular, Temple said trials that randomize non-responders to a drug to receive both that drug and an alternative drug have "a lot of potential" but are almost never done. "For example, you could take people who don't respond to a migraine drug and randomize them back to a new migraine drug, the old migraine drug the one they didn't respond to, and a placebo. If it's true that there are individual differences that are important, then the new drug ought to be able to show its advantage over the drug that didn't work," he wrote in a post on FDA's From a Clinical Perspective blog. ...