Wednesday, December 17, 2008

'A randomized discontinuation study'

I'll admit it: I felt a little smarter just typing that. I mentioned (threatened?) earlier that I wanted to say a little bit about the brivanib protocol, because it strikes me as interesting and somewhat unusual. I barely have any experience at all with clinical trials, and I've already learned an obvious yet somehow counter-intuitive point: The trials aren't designed to help you. They are designed to bring safe, effective drugs to market as quickly as possible. If they help you, that's great, but it's not the primary goal.

Anyway, the study works like this: You get the drug for sure for 12 weeks. If your tumor grows, you're out of the study. If your tumor shrinks more than 20 percent or so, you stay on the drug for sure. If your tumor remains essentially the same size, you are randomized into a double blind, placebo-controlled group. You may get the drug, you may get the placebo (ugh). If your tumor grows, they unblind the study to find out whether you are receiving brivanib or placebo. If your tumor grew on the placebo but was stable on the drug, they will switch you back to the drug. The protocol requires scans every six weeks, so it looks to me like the time off-drug could be relatively short.

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