(Total Views: 187)
Posted On: 01/05/2017 12:28:36 AM
Post# of 72447
Good post. I just showed an example which the trial was ended early due to positive interim data.
"The decision to stop FLINT has been based on the recommendation of the Data Safety Monitoring Board (DSMB) which reviewed liver biopsy data from before and at the end of the treatment period in approximately half of the 283 randomized patients, in accordance with a planned interim efficacy analysis."
http://ir.interceptpharma.com/releasedetail.c...eid=818119
"This means that if a treatment is particularly beneficial or harmful compared to the concurrent placebo group while the study is on-going, the investigators are ethically obliged to assess that difference using the data at hand and to make a deliberate consideration of terminating the study earlier than planned."
https://en.wikipedia.org/wiki/Interim_analysis
"The decision to stop FLINT has been based on the recommendation of the Data Safety Monitoring Board (DSMB) which reviewed liver biopsy data from before and at the end of the treatment period in approximately half of the 283 randomized patients, in accordance with a planned interim efficacy analysis."
http://ir.interceptpharma.com/releasedetail.c...eid=818119
"This means that if a treatment is particularly beneficial or harmful compared to the concurrent placebo group while the study is on-going, the investigators are ethically obliged to assess that difference using the data at hand and to make a deliberate consideration of terminating the study earlier than planned."
https://en.wikipedia.org/wiki/Interim_analysis
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