While we are waiting for our own PhIII trial results here's an...

While we are waiting for our own PhIII trial results here's an interesting read...

"Drug development is a tough business. Sometimes, just when you think you're getting to the pot at the end of the rainbow, you find the trap door one step away.

It's not supposed to work that way. The further you get down the pipeline, the better your shot at success. By the end of Phase II, investigators are supposed to have a solid set of significant safety and efficacy data on humans. Phase III is where the big bets are made, based on good science and some unprecedented demands for new products.

Sometimes, though, it's hard to tell where the science leaves off and the magical thinking begins. The desire to score a modest clinical success for Alzheimer's, an automatic gold ticket to a megablockbuster market entré, convinced some experts to push ahead with some incredibly risky bets--which flopped. The same goes for hepatitis C, where there's gold at the end of a rainbow for the first interferon-free drug to hit the marketplace.

About a third of all Phase III studies end in disaster. The analyst Tim Anderson recently produced a report pointing to a 65% success rate, which is down from the 70% success rate tracked just a few years ago."


http://www.fiercebiotech.com/special-report/top-phase-iii-disasters-2012/2012-10-02#ixzz2Av2hUaMI