Saturday, March 03, 2018 4:33:30 PM
I could understand one or two unethical investigators, but 65???
Hmm. You assume several facts not in evidence. First, the investigators can't make a decision to publish at this stage; they don't have access to the aggregate data - only the sponsor does. Second, for an ongoing trial, whether anything can be published at all is entirely the sponsor's choice alone (this would be true even with a single-center trial). I'm surprised you don't know this, this is spelled out in virtually all investigator agreements.
That being said, that NWBT made the choice to publish now means, obviously, that the data are quite favorable and compelling, even though blinded, blended, and from an ongoing trial. The sponsor having made this decision, the fact that 65 PIs lined up to put their names on it also points to positive results (which of course was my point about the 65 PIs: not the decision itself but the climbing onboard). If they were not, any PI who didn't want to be associated with prematurely publishing blinded/blended data showing nothing (and there would be plenty of them) would not be unethical and could not be accused of it - they would just be sensible, uninterested at best, and at worst not wanting to tarnish their reps with the inexplicable (under your "negative" scenario), premature publication of data showing little or no benefit in a blinded ongoing trial. As an investigator I can tell you I'd be in no rush to put my name on that and in fact I'd counsel the sponsor against proceeding with a publication.
Other than that, strong point.
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