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Posted On: 11/04/2024 7:32:30 PM
Post# of 148870
Quote:
I might be off target here...it certainly happens...my understanding...limited as it may be...is that wanting to look at interim results halfway through a trial has a deleterious effect...on significance of results.
The FDA wouldn't penalize a trial if the results are only known to the Data Safety Monitoring committee that is part of their job. However if the trial results are released to the drug company or those running the trial then the data is seen as being compromised and it could affect the trial outcome. If you're going to release the results mid-trial you'd better have excellent results that will overcome any FDA objections.
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