Biotech Values

[DewDiligence]

Re: PLX4032 and investigator “cheating”

I find it amazing that the trial investigators feel that they can add to the protocol in a very substantive way. Of course it is only a ph 1—but I would have never guessed that this kind of protocol addition by an individual investigator would be considered acceptable.

Clinicians can get away with stuff in phase-1 that would be hard to do in phase-2 and would be nearly impossible to do in phase-3. Today’s NYT article posted by Bulbaman (#msg-54567652) shows how well (or how badly, depending on your point of view) the clinical-trial system works to protect data integrity in phase-3.