Efficacy stop is an emergent situation??? I have n
Post# of 154849
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Posted On: 08/03/2020 6:05:24 PM
Efficacy stop is an emergent situation??? I have no primary sources about how DSMCs work, let alone who they communicate with after they chat, but it seems to me that if the DSMC judges an efficacy stop then that creates an emergent situation requiring immediate action.
If efficacy stop, the DSMC is essentially declaring an emergency situation.
Placebo patients are expected to die within days because they got placebo.
You can't let the placebo patients hang out to dry. All of them have to get treatment immediately because the DSMC has determined that placebo patients are likely to die if left untreated.
I don't think the DSMC can recommend an efficacy stop and then put a letter out for the US postal service.
The party responsible for executing the efficacy stop must do so immediately or else it seems to me that party might be liable for a wrongful death lawsuit.
In the s/c trial, i think the efficacy stop criteria must be determined before the meeting even takes place.
you just make an (x,y) list. For each number of placebo deaths from 0 to 50, there is a treatment arm death number that signals efficacy stop.
Just look it up. It takes less than five seconds.
Seems to me efficacy stop is trivial to calculate, and if judged must be implemented immediately.
But who knows, maybe there is way for the DSMC to pass the buck to someone else. Certainly a lot of pressure on the DSMC in this case.
If efficacy stop, the DSMC is essentially declaring an emergency situation.
Placebo patients are expected to die within days because they got placebo.
You can't let the placebo patients hang out to dry. All of them have to get treatment immediately because the DSMC has determined that placebo patients are likely to die if left untreated.
I don't think the DSMC can recommend an efficacy stop and then put a letter out for the US postal service.
The party responsible for executing the efficacy stop must do so immediately or else it seems to me that party might be liable for a wrongful death lawsuit.
In the s/c trial, i think the efficacy stop criteria must be determined before the meeting even takes place.
you just make an (x,y) list. For each number of placebo deaths from 0 to 50, there is a treatment arm death number that signals efficacy stop.
Just look it up. It takes less than five seconds.
Seems to me efficacy stop is trivial to calculate, and if judged must be implemented immediately.
But who knows, maybe there is way for the DSMC to pass the buck to someone else. Certainly a lot of pressure on the DSMC in this case.
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