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re: Eli Lilly pauses trial of antibody drug Trump touted as COVID-19 'cure' over safety concer
Posted on 10/13/20 at 5:53 pm to DougsMugs
Posted on 10/13/20 at 5:53 pm to DougsMugs
quote:
J&J said it does not yet know if that person was given the vaccine or a placebo."
So you stop a trial before knowing if the illness MAY even be due to the actual medication.
Jesus Christ
Posted on 10/13/20 at 9:56 pm to Lsut81
quote:
So you stop a trial before knowing if the illness MAY even be due to the actual medication.
Yes.
There are 1000 people a day receiving this experimental drug. Neither the doctors, the patients, nor the drug company know who is receiving active drug and who is receiving the placebo. There's a list of "anticipated" side effects (also called Adverse Events), fever, muscle aches, lethargy for example, that are recorded but aren't going to raise a red flag. There may also be a list of side effects that will immediately stop the trial. This might be any Serious Adverse Event (by definition those are life threatening, require hospitalization, or result in death) or a subset...I don't have this particular protocol on hand so won't speak to the specifics.
Anywho...if one of these triggers are reported, everything stops until the independent Data Safety Monitoring Board (DSMB) is able to review all available data in an unblinded fashion. This takes a couple of days because the site (the doctor or hospital) has to of course first treat the patient, record everything about the case in the study database and likely have telephone or email conversations with the medical monitor of the study. That information is provided to the DSMB along with aggregate data to date to allow them to make a decision as to whether or not it is reasonable to proceed as-is, or with modifications to the protocol. Perhaps with additional safety monitoring, or further restricting the patients allowed to enroll (maybe it was a heart issue so now you need to exclude patients with pre-existing heart disease, as an example.)
This is how research works pandemic or no pandemic. If all is well, it is only setting the study back by a matter of days. If there IS a problem, it saves innocent volunteers' lives.
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