Thriftycents, It is my understanding that there
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Posted On: 08/02/2020 3:22:31 PM
Re: thriftycents #46670
Thriftycents,
It is my understanding that there will not be any p-scores calculated by the Data and Safety Monitoring Board (DSMB) overview.
These are calculated in the interim analysys which will take place sometime latter when we enroll more patients (maybe two-three weks doen the road at the current enrollment rate).
There is one possible scenario though: The safety board finds out that overwhelmingly the majority of the deaths are in the placebo group (as compared with Lero's).
They then have the possibility of stopping the trial where not further test is necessary (stop for efficacy). When this happens they, or a Clinical Endpoint Committee (CEC) will evaluate a p-number in statistical support for the termination of the trial, and/or modification of the rial to de-risk part of the patients (for example, administer Leronlimab to the patients still being treated with placebo immediately).
However, for p-values we will need to wait for the interim analysis where this will be calculated together with the other predefined trial outcomes
It is my understanding that there will not be any p-scores calculated by the Data and Safety Monitoring Board (DSMB) overview.
These are calculated in the interim analysys which will take place sometime latter when we enroll more patients (maybe two-three weks doen the road at the current enrollment rate).
There is one possible scenario though: The safety board finds out that overwhelmingly the majority of the deaths are in the placebo group (as compared with Lero's).
They then have the possibility of stopping the trial where not further test is necessary (stop for efficacy). When this happens they, or a Clinical Endpoint Committee (CEC) will evaluate a p-number in statistical support for the termination of the trial, and/or modification of the rial to de-risk part of the patients (for example, administer Leronlimab to the patients still being treated with placebo immediately).
However, for p-values we will need to wait for the interim analysis where this will be calculated together with the other predefined trial outcomes
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