RE: DSMB info
Re read your post....
In multi-center studies, performance monitoring should be an ongoing activity performed by the study investigator and statistician, and reviewed by the DSMB. Performance data are reviewed in a blinded fashion, often in aggregate by site, and thus do not raise unblinding or bias issues. The investigator and statistician also perform ongoing safety review of the data, and safety reports are reviewed at regularly scheduled DSMB meetings.
The performance monitoring is an ongoing activity performed by the study investigator and statistician as well as ongoing safety reviews. This is unblinded - the DSMB then reviews the activity of the study investigator and statistician which is normally provided via report from the statistician blinded.
Also, read the post from earlier in the thread discussing DMC protocol...notice the DMC evaluates unblinded results.
A clinical trial is only unblinded in the sense that very few if any one person has immediate access to all the performance off the therapy during the trial but many individuals have access to certain pieces of information. The clinical pharmacist in each centre is aware of which therapy each patient is receiving and this information is stored in each centre. The randomization centre is aware of and documents which therapy ALL patients across all centres are receiving and communicates this information to the study statistician. There are a few others who by necessity have unblinded access to study information.
Take is all with a grain of salt.