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Msg  3462 of 4823  at  7/13/2020 11:01:04 AM  by


The following message was updated on 7/13/2020 11:04:15 AM.

Adaptive design

Here is the FDA guidance for a trial with an adaptive design, such as the severe-critical trial in covid-19:
Under point (3) in my previous post, it states:
"Third, a trial terminated early for efficacy will have a smaller sample size for the evaluation of safety and potentially important secondary efficacy endpoints. Therefore, early stopping for efficacy is typically reserved for circumstances where there are compelling ethical reasons (e.g., the primary endpoint is survival or irreversible morbidity) or where the stopping rules require highly persuasive results in terms of both the magnitude of the estimated treatment effect and the strength of evidence of an effect. In some cases, there may be a limit on how early group sequential interim analyses should occur or whether they should occur at all because of a minimum sample size expected for a reliable evaluation of safety."
Also, in terms of the role of the DSMC, it states:
"Alternatively, the adaptive decision-making role could be assigned to the DMC, although its primary responsibility should remain to ensure patient safety and trial integrity."

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Msg # Subject Author Recs Date Posted
3464 Re: Adaptive design rubraquercus 6 7/13/2020 11:14:05 AM

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