However, in the first case you argued a cost-driven consideration to explain the small placebo side, and in the second sheer bull-headedness and stupidity on the part of those who (in this case) designed this RPRX trial.
The point, very simply, is that biotech have an OVERWHELMING history of making poor decisions about trial design - whether it is from false economy or shear ignorance of history (e.g. they never learn from their neighbors in the biotech world that changing entry criteria is far from benign no matter how well intentioned.)
If we want to claim that somehow RPRX management is different then they need to explain WHY they are smarter. Why they are different. What 5 calls have they made that were really good. Or prove that they have designed this trial correctly. But I would suggest that it is a mistake to assert that no designer/statistician would make such a mistake WHEN HISTORY SAYS THEY MAKE THEM ALL THE TIME. It seems to be small biotech culture.
What I find disturbing about this board is the amount of cool-aid as evidenced by the complete lack of curiousity about any of the details of trial design. In contrast, for Provenge there are a variety of longs at least asking what the interim is, what the Cox Regression coefficients are, ... . Where is that spirit here? I would suggest that it should worry you that there is no such curiousity here.
As to the lack of randomized p II trials in cancer research... I'd see that in the more cynical light of being more driven by the desire to get lucky by not asking too much of the phase II's
Well, my cynicism runs more along the lines of the edict never to assume malfeasance when incompetence is an adequate explanation - and I have seen plenty of outright incompetence in data interpretation and trial design. By companies with bigger names than the repros team.
The sorry thing here is that my first pass at the repros mgt team gives them higher than normal marks - but I may not get to a second pass because I cannot get better data with which to calibrate them.
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