Re[2]: Early Unblinding in Phase III

From: Mo_Noursalehi@rdsi.ccmail.compuserve.com Subject: Re[2]: Early Unblinding in Phase III Date: 22 Jul 1997 11:49:41 -0400 Dear Conni, Under regulatories in U.S., you may not break the blind for your analysis regardless of how short the time is. But, there are other alternatives. For example, why can't you use A, B, ... names for your placebo, active drug 1, ... (which I am sure is already assigned to them to maintain the blind) and perform your analyses. Once data sets are locked and blind broken according to the SOP, you may, one last time, run your already-prepared programs with the proper randomization information. I hope it is clear, if not, you may write to me directly and we will discuss it further. Regards, Mo Noursalehi, Ph.D.