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May 1, 2012
John LaMattina has a good piece up on the FDA, where they might be trying to have it both ways. About a recent speech by Janet Woodcock, he has this:
But Dr. Woodcock begins to stray into areas where I think she is off base. For one thing, she asserts that “many late stage [clinical] failures are due to efficacy problems.” That’s not exactly true. It is only when companies take compounds into late stage development with little or poor proof-of-concept data where this happens. The majority of phase 3 clinical trial failures are due to unforeseen, unpredicted side-effects or else due to finding that, in direct comparison to existing therapy, the new drug doesn’t show the superiority necessary to be successful commercially. Dr. Woodcock goes on to advocate for the generation of “evaluative tools,” new methodologies that can better predict the performance of a compound in late stage studies.
Of course, those tools are a good idea, and would be worth a lot (which is why everyone's been spending time and money trying to find them). But the FDA will not approve drugs based on them. They probably shouldn't - as LaMattina says, there have been quite a few drugs in recent years that looked like they would work based on one secondary endpoint or another, only to come up short in the real world. Woodcock is right to call for such approaches, but they won't necessarily shorten the time until approval. The hope is that they'll save time and money another way, in letting us kill projects earlier, with some hope of being right. Anything that spares us an unnecessary Phase II, or especially an unnecessary Phase III, is a good thing. But the eventual drug is going to have to jump through all the hoops, same as before.
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