iwfal:
<<<"This would almost always (I know of no exceptions - but won't swear there are none) be only per pre specified trial protocol. I.e. Interim looks by the DMSB can only stop a trial for bad events unless it is pre-specified by the company that they are willing to spend some p on the interim look.">>>
Minor point of info - the SPPI / GPCB trial I believe had an unplanned look at survival - almost certainly there was an early survival benefit that piqued their interest - we know this because the next (planned) look the trial was stopped on the surrogate. It is reasonable to assume, seeing as the look was announced in advance, that stopping was on the table (ie a material event).
"....on the biotech battle-field, you need some élan...."
