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Re: jfmcrr post# 100533

Friday, 02/17/2017 2:17:58 PM

Friday, February 17, 2017 2:17:58 PM

Post# of 426389
JF - Not exactly. What I recall posting was about what can happen when trials stop early vs. not, with an example of a trial that could have stopped early with significance ending up being continued and being nonsignificant on completion. It obviously is more common to be nonsignifcant at early interim but significant later due to increased event numbers. My take on the ethics of an early stop of R-it is that this is an unusual case because V is already approved and available to anyone who wants it (potentially). Ethicists could argue that V as an effective treatment to reduce CV risk is not being withheld since it is already available, and therefore the ethical need to stop early for overwhelming efficacy is not as compelling, and must be balanced by the benefits to other patients (from greater strength of the secondary outcomes) if the trial is continued.
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