Thursday, September 25, 2008 10:06:09 AM
That is to completely miss the point.
Of course PSB exists, just as "weak gravitational forces" or light summer breezes exist.
However it has been trumpeted by the demagogues as the "cause" of various P3 failures. These people make the case that the specific biotechs should have known better not to trust their specific P2 results - and because of PSB. Inherently, they claim to bs "smarter" than the entire trial team.
Whereas the real truth is that the factors that go into P3 trial failures are vastly more broad.
Furthermore, as a Group, even if it was the industry that was running the P3 trials, there is NOTHING the industry can do about this slight PSB bias. Larger P3s are not the answer, if a stat-sig result on an inadequate HR or meaningless median survival benefit is worthless.
"....on the biotech battle-field, you need some élan...."
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