The following is from the PR on October 20 The DS
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Posted On: 10/23/2020 8:48:50 PM
The following is from the PR on October 20
The DSMC had three recommendations to consider following its review of the interim analysis:
Stop the trial due to safety concerns;
Continue the trial with modification (i.e., increase the sample size to maintain the power to achieve the primary endpoint); or
Continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint.
I thought NP was just trying to make the recommendation look as positive as possible by not mentioning that haulting the trial for overwhelming benefits was an option. He also never mentioned that stopping the trial for overwhelming benefit was an option in the most recent CC. My question is was it an option? I like most if not all believed it was an option.
The DSMC had three recommendations to consider following its review of the interim analysis:
Stop the trial due to safety concerns;
Continue the trial with modification (i.e., increase the sample size to maintain the power to achieve the primary endpoint); or
Continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint.
I thought NP was just trying to make the recommendation look as positive as possible by not mentioning that haulting the trial for overwhelming benefits was an option. He also never mentioned that stopping the trial for overwhelming benefit was an option in the most recent CC. My question is was it an option? I like most if not all believed it was an option.
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