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Posted On: 07/18/2020 5:18:41 PM
Post# of 148908
Re: reallypeople? #43645
The trial sites do not have statistical software.
The sites collect the data and get it to the trial sponsor.
The trial sponsor analyzes the data from all the sites combined to determine efficacy and safety. The data is evaluated according to the predefined SAP (statistical analysis plan).
Another person questioned if all the sites data was in and the answer must be yes. The process of locking the database means that all data is in and any open queries are resolved. Once Database is locked no new data can be added - it is after this that the data is unblinded.
In my experience it take longer than a few minutes for the statisticians to run all programs and create and publish the data tables but with some weekend work, the main results could be known.
To get everything FDA submission ready takes some time but we should hear the top line results soon.
IMO
The sites collect the data and get it to the trial sponsor.
The trial sponsor analyzes the data from all the sites combined to determine efficacy and safety. The data is evaluated according to the predefined SAP (statistical analysis plan).
Another person questioned if all the sites data was in and the answer must be yes. The process of locking the database means that all data is in and any open queries are resolved. Once Database is locked no new data can be added - it is after this that the data is unblinded.
In my experience it take longer than a few minutes for the statisticians to run all programs and create and publish the data tables but with some weekend work, the main results could be known.
To get everything FDA submission ready takes some time but we should hear the top line results soon.
IMO
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