The odds of successful drug development

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The odds of successful drug development

Postby dignan » Tue Sep 21, 2004 10:32 am

Interesting information about the odds of getting a drug approved in the US.

"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.

...that translates to about a 11% success rate from starting in the clinic. "

http://www.corante.com/pipeline/archive ... t_odds.php
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Postby mscaregiver » Tue Sep 21, 2004 2:11 pm

More information concerning the big pharms and development and how the system works, extremely eye opening..

http://www.nybooks.com/articles/17244
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Postby unknown » Wed Sep 22, 2004 8:49 am

I know we all hate the big pharma, but being an insider (AARRGGHHH!!!!!!) I can say that the attrition rates have improved dramatically over the last ten years, more and more drugs are making it past phase I, II and III - believe me my workload is increasing by the day!!

Although such statements may seem to be bad news, there is a positive when you compare the rates in recent years!
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Postby dignan » Wed Sep 22, 2004 12:00 pm

mscaregiver,

This is an interesting reply (from the same place as my first link posted) to some of the points raised in the book that was reviewed in the link you posted.

http://www.corante.com/pipeline/archive ... _works.php

Not sure where I stand on it, but it's definitely a complex issue.
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