BACKGROUND:
Interim analysis of Phase III trials typically includes testing for both efficacy and futility. Futility testing is commonly performed on the primary outcome at very low levels (e.g., one-sided alpha=0.0025) at one or two times before final analysis. When overall survival is the primary outcome and events accrue slowly, and if a suitable intermediate endpoint is available, then using this endpoint for interim futility testing may yield a higher probability of stopping early for futility in the absence of any treatment effect.
https://www.ncbi.nlm.nih.gov/pubmed/18283075
Recently, Argos (dendritic) failed their interim futility while Mesoblast passed.
Argos:
the IDMC recommended it be stopped because a statistically significant survival benefit was not being shown in the trial arm relative to control, and in their recommendation, they did not see a chance where such a benefit could be met if the trial was allowed to continue until 100% of events (patient deaths) occurred in both arms.
https://seekingalpha.com/article/4050153-argos-therapeutics-store-adapts-failure
Mesoblast:
The dataset for the interim analysis includes non-fatal and terminal cardiac events from the first 270 of the anticipated 600 patients to be included in this ongoing trial. The IDMC will review and interpret the results of the interim analysis and provide recommendations shortly.
https://globenewswire.com/news-release/2017/03/31/947518/0/en/Independent-Data-Monitoring-Committee-Initiates-process-for-Interim-Analysis-of-Mesoblast-s-Phase-3-Chronic-Heart-Failure-Trial.html
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