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Posted On: 06/03/2021 12:07:40 PM
Post# of 72440
The only way that patient deaths would become known would be if the safety committee that monitors the clinical trial noticed LOTS MORE deaths in the DRUG group. That would indicate that the drug was dangerous and the clinical trial should be stopped. In Brilacidin's case, we know from previous studies that the drug is safe at these doses so that's not an issue.
That's what they mean by results being "blinded." We don't know what they are until the study is completed.
However if it seems that patient deaths are caused by a drug, that's when the safety committee steps in and halts the trial.
The only other possibility would be if the group that received the drug had spectacularly fewer deaths, then the monitoring committee might suggest unblinding early. With such a small study, the chances of that happening are close to zero.
That's what they mean by results being "blinded." We don't know what they are until the study is completed.
However if it seems that patient deaths are caused by a drug, that's when the safety committee steps in and halts the trial.
The only other possibility would be if the group that received the drug had spectacularly fewer deaths, then the monitoring committee might suggest unblinding early. With such a small study, the chances of that happening are close to zero.
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