Why winners fail in clinical trials

I constantly mention failures in clinical trials. I have the impression that Big Pharma needs to brag about all of potential candidates in pipe-lines – it is a part of the game due to PR-activity increases values and capitalization of Big Pharma. And here we can see that later on the candidates fail on clinical trials – as it should be very simply expected:

A new study that has examined the results of thousands of clinical trials has determined that 90% of the early winners failed to continue to produce the same clinical effect in later studies. A whopping 98% of the follow-on studies that did see a big effect failed to continue to wow investigators in subsequent trials.

So why is disappointment the ultimate rule for drug developers? Dr. John Ioannidis at Stanford says the big reason is trial size. If you study a drug in a small trial, random positive responses tend distort the results, skewing the data in a way that wows developers.

"I think some healthy skepticism and a conservative approach may be warranted if only a single study is available--even more so if that study is small and/or had obvious problems and biases," Ioannidis tells HealthDay. "Most of the time, waiting for some better, larger, more definitive evidence is a good idea. No need to rush."

Well, I completely disagree that the only reason of the failures is a size of the trials – the failures is a part of the game, they are the trade-off of a PR-activity which is designed to provide some kind of evidence THAT Big Pharma has capacity and potential to launch novel promising drugs. And I have written earlier that Big Pharma basically is not very interesting in innovations.

Here is top 5 failures of 2012. Very interesting...