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September 20, 2004
Drug Development: The Current Odds
The August issue of Nature Reviews: Drug Discovery has an alarming article on the attrition rates in drug development. I often get questions about these figures, and it's good to have a fresh look at the data. Among the ten largest pharma companies, in the period 1991-2000, here's the breakdown:
38% of the drugs taken in the the clinic dropped out in Phase I (safety / blood levels.)
60% of those remaining failed in Phase II (basic efficacy.)
40% of the remaining candidates failed in Phase III (big, expensive efficacy.)
And 23% of the ones that made it through the clinic failed to be approved by the FDA.
You can do the math as quickly as I can: that translates to about a 11% success rate from starting in the clinic. And consider that for someone like me, back in the research labs, a successful program is one that makes it to Phase I. It's no wonder that so few medicinal chemists have ever worked on a drug that's made it all the way to market!
The other thing to keep in mind, in light of last Friday's post, is that the money spent on these things grows terribly along the way. A failure in Phase I isn't pretty, considering the time and money spend in the preclinical period (aka: what I spend all my working life doing.) But a failure in Phase III or at FDA time is a financial disaster.
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