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Are "data cut off" and "data lock" the same thing in a clinical trial?
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Laurence Konersman
Are "data cut off" and "data lock" the same thing in a clinical trial?
I don't think they are both specific terms that will apply consistently across all studies, you will have to use the surrounding context.
"Data lock" typically means that the data themselves in some sort of database are no longer being edited and are ready to be analyzed: that is, they have been recorded, checked for accuracy, etc. to create a "final" version. A synonym is "data freeze". It is usually referring more to the database itself, though, rather than data collection for the study. Indeed, in this passage, it seems like they finished collecting data in Feb 2017, but finalized the database in Oct 2017.
The purpose of a data lock/data freeze is to prevent statistical "fishing" in the data, for example by re-analyzing data until some significance threshold is reached, or making decisions about exclusion criteria after preliminary statistical analyses have been completed. The proper procedure is to get your data in the best condition they can be in, and then begin analysis.
The only sensible interpretation of their meaning of "data cut-off" in this context is that it refers to the end of the follow-up period in Feb 2017: since follow-up stopped then, they wouldn't know reasons for discontinuation past then. The study is frozen in time at the time they stopped recording data. I am not aware of this phrase being used as a specific term (unlike data lock or data freeze), I think they are just using the general English meaning of those words to describe "the time after which we didn't collect any more data."
I don't think they are both specific terms that will apply consistently across all studies, you will have to use the surrounding context.
"Data lock" typically means that the data themselves in some sort of database are no longer being edited and are ready to be analyzed: that is, they have been recorded, checked for accuracy, etc. to create a "final" version. A synonym is "data freeze". It is usually referring more to the database itself, though, rather than data collection for the study. Indeed, in this passage, it seems like they finished collecting data in Feb 2017, but finalized the database in Oct 2017.
The purpose of a data lock/data freeze is to prevent statistical "fishing" in the data, for example by re-analyzing data until some significance threshold is reached, or making decisions about exclusion criteria after preliminary statistical analyses have been completed. The proper procedure is to get your data in the best condition they can be in, and then begin analysis.
The only sensible interpretation of their meaning of "data cut-off" in this context is that it refers to the end of the follow-up period in Feb 2017: since follow-up stopped then, they wouldn't know reasons for discontinuation past then. The study is frozen in time at the time they stopped recording data. I am not aware of this phrase being used as a specific term (unlike data lock or data freeze), I think they are just using the general English meaning of those words to describe "the time after which we didn't collect any more data."
I don't think they are both specific terms that will apply consistently across all studies, you will have to use the surrounding context.
"Data lock" typically means that the data themselves in some sort of database are no longer being edited and are ready to be analyzed: that is, they have been recorded, checked for accuracy, etc. to create a "final" version. A synonym is "data freeze". It is usually referring more to the database itself, though, rather than data collection for the study. Indeed, in this passage, it seems like they finished collecting data in Feb 2017, but finalized the database in Oct 2017.
The purpose of a data lock/data freeze is to prevent statistical "fishing" in the data, for example by re-analyzing data until some significance threshold is reached, or making decisions about exclusion criteria after preliminary statistical analyses have been completed. The proper procedure is to get your data in the best condition they can be in, and then begin analysis.
The only sensible interpretation of their meaning of "data cut-off" in this context is that it refers to the end of the follow-up period in Feb 2017: since follow-up stopped then, they wouldn't know reasons for discontinuation past then. The study is frozen in time at the time they stopped recording data. I am not aware of this phrase being used as a specific term (unlike data lock or data freeze), I think they are just using the general English meaning of those words to describe "the time after which we didn't collect any more data."
I don't think they are both specific terms that will apply consistently across all studies, you will have to use the surrounding context.
"Data lock" typically means that the data themselves in some sort of database are no longer being edited and are ready to be analyzed: that is, they have been recorded, checked for accuracy, etc. to create a "final" version. A synonym is "data freeze". It is usually referring more to the database itself, though, rather than data collection for the study. Indeed, in this passage, it seems like they finished collecting data in Feb 2017, but finalized the database in Oct 2017.
The purpose of a data lock/data freeze is to prevent statistical "fishing" in the data, for example by re-analyzing data until some significance threshold is reached, or making decisions about exclusion criteria after preliminary statistical analyses have been completed. The proper procedure is to get your data in the best condition they can be in, and then begin analysis.
The only sensible interpretation of their meaning of "data cut-off" in this context is that it refers to the end of the follow-up period in Feb 2017: since follow-up stopped then, they wouldn't know reasons for discontinuation past then. The study is frozen in time at the time they stopped recording data. I am not aware of this phrase being used as a specific term (unlike data lock or data freeze), I think they are just using the general English meaning of those words to describe "the time after which we didn't collect any more data."
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