I wrote an email to Larry asking about the possibility that the...

I wrote an email to Larry asking about the possibility that the trial might be unblinded. Here's his timely response (and on a Sunday too):


"During the course of the study, the Medical Monitor reviews data in more or less real time as it’s entered into the database. That’s primarily focused on safety and tolerability however and, because he doesn’t know which subjects are on drug and which are on placebo, it’s not possible to determine drug effects.

The DSMC reviews consolidated data on a predetermined schedule or in the event of a serious adverse event. If it were to become starkly clear that some patients appeared to be benefitting dramatically while others showed no effect, the DSMC could request an unblinded interim analysis but, in practice, that’s quite unusual."

(DSMC = Data and Safety Monitoring Committee)