The odds of successful drug development

dignan · Post by **dignan** » Tue Sep 21, 2004 9:32 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

Post by **mscaregiver** » Tue Sep 21, 2004 1:11 pm

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

http://www.nybooks.com/articles/17244

unknown · Post by **unknown** » Wed Sep 22, 2004 7:49 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!

dignan · Post by **dignan** » Wed Sep 22, 2004 11:00 am

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.