Every institution that engages in drug trials must
Post# of 147655
(Total Views: 787)
Posted On: 12/25/2020 2:41:56 AM
Re: Good to go #69651
Every institution that engages in drug trials must have an Institutional Review Board (IRB) which is responsible for watching closely the safety of those drug trials.
They report immediately to the FDA and the trial sponsor (in our case, Cytodyn) any Adverse Events and Serious Adverse Events that happen during a trial.
They have the power to end a trial if they see that the trial drug is doing more harm than good.
In order to do their job, they are not blinded to which patient is getting which drug. They, no doubt, tell the FDA which arm of a double-armed study is having EAs and SEAs. So the FDA knows at least that much of how well a study is going. They also can call a halt to a trial.
The sponsor is, I'm sure, not told which arm may be experiencing the adverse events.
Since a decrease in mortality in S/C Covid patients is the endpoint for the CD12 trials, I think the FDA can judge pretty well whether Leronlimag is working or not. Their label expansion for Leronlimab pretty well confirms that the trials are going Leronlimab's way. A very positive thing!
They report immediately to the FDA and the trial sponsor (in our case, Cytodyn) any Adverse Events and Serious Adverse Events that happen during a trial.
They have the power to end a trial if they see that the trial drug is doing more harm than good.
In order to do their job, they are not blinded to which patient is getting which drug. They, no doubt, tell the FDA which arm of a double-armed study is having EAs and SEAs. So the FDA knows at least that much of how well a study is going. They also can call a halt to a trial.
The sponsor is, I'm sure, not told which arm may be experiencing the adverse events.
Since a decrease in mortality in S/C Covid patients is the endpoint for the CD12 trials, I think the FDA can judge pretty well whether Leronlimag is working or not. Their label expansion for Leronlimab pretty well confirms that the trials are going Leronlimab's way. A very positive thing!
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