Isn’t it more likely that whatever entity shipped the placebo/treatment vials simply kept a running total of “number of patients who received placebo”, “number of patients who received treatment,” and reported that number at some point?
If the aggregated number originated from the shippers, how does it break the blind since patients and trialists still wouldn’t know who specifically received treatment?
Apologize if this has already been well-covered previously but I don’t remember any details on this broken blind theory in the last six months.
The above procedure is entirely consistent with Cognate keeping an aggregate total of the number of patients for which it shipped DCVax-L, while still maintaining the blind for the sponsor, clinicians and patients. It is data that the sponsor would be interested in, and could potentially act as a value to check against for data intregrity.
It would be most accurate for Cognate to call this the “number of patients for which DCVax-L was shipped.” It would be entirely natural that LL would use the same term in the JTM article, even though it might be slightly less accurate, given the remote possibility that DCVax-L was shipped for a patient who for some reason never received the treatment. Hit by a bus crossing the street to the clinic jumps to mind.
No need to rifle through shipping records is necessary. No breaking of the blind. Certainly no admission that either ever happened.