Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

It is futile to suggest no futility checkpoint...



https://pdfs.semanticscholar.org/7d4c/09dd2d8333277b8ffe287609e0982f0ce26a.pdf

Interim analyses
An interim analysis for futility and efficacy will be performed after primary outcome data are available for the first 168 participants (50%) to enroll. The study will be terminated for futility if the interim analysis shows that the conditional power of rejecting the null hypothesis in favor of a beneficial effect of isradipine is lower than 20% under any scenario that is consistent with the data accrued at that time. A two-sided P-value in favor of isradipine of less than 0.001 will be required to stop for efficacy at the interim analysis. The stringent alpha level for efficacy was chosen so as to have minimal effect on the final P-value, should the study run to completion. In addressing futility, the DSMB will examine a range of possible treatment effects consistent with the data obtained in the study at the time of analysis.

Not only did the study pass through the futility checkpoint, that checkpoint was complete 3 year data on 168 patients. Many full studies aren't even that big. The study was designed to detect if there was at least 25% slowing of functional decline with isradipine, and it would have been stopped if it didn't look like it was happening after 50% of participants had completed the study.