On S/C, perhaps Pourhassan is blinded but still in

On S/C, perhaps Pourhassan is blinded but still informed?

Maybe Patterson is fully unblinded.

Maybe Pourhassan calls Patterson and says, "Do we know the result on the primary endpoint for the S/C trial?"

Maybe Patterson replies, "Yes".

Maybe Pourhassan follows up with, "Should we report interim results or wait for further enrollment?"

Maybe Patterson replies, "We should report interim results."

At this point, Pourhassan remains "fully blinded" despite the fact that Pourhassan knows the primary endpoint outcome on the.

It strikes me that the legal and ethical requirements for "blinding" in a placebo controlled FDA trial do not extend to mind reading.

I suspect that the "blinding" protocol is limited to specific things, like communication between trial investigators, communication of data results, custody of data results.

I suspect that the FDA "blinding" protocols do not anticipate a situation where a single laboratory doing a single lab test (in this case Patterson doing receptor occupancy) is effectively unblinded as to not only which patients receive placebo but also the primary outcome.

If indeed the FDA "blinding" protocols do anticipate effective unblinding by some sort of diagnostic worker (in this case Patterson), then probably also those anticipatory blinding regulations would probably legally enjoin the anticipated unblinded individual (Patterson in this case) from communicating with any other trial entity, perhaps as to any communication (You can't speak to any of these people for any reason.). And perhaps the anticipated unblinded worker is also legaly enjoined from speaking to any non-trial entity regarding any aspect of the trial.

It just seems to me that the FDA either has, or does not have, some sort of mind reading clause, like "If you learn a secret you must keep it".