Common use of Interim Analysis Clause in Contracts

Interim Analysis. An interim analysis designed to evaluate effectiveness for continuing crossover of control arm study participants after the 1 year follow-up visit to EBV treatment will be performed when 74 (50% of the required minimum of 147) study participants have completed the 1 year follow-up. If crossover of control arm study participants is found to be justified by the interim analysis then crossover of a control arm study participant after (s)/he has reached the 1 year follow-up time point may be continued. The results of the interim analysis will be reviewed by the DSMB and FDA. If the DSMB recommends not continuing crossing control arm participants to EBV treatment then those control arm participants who have not crossed over will exit from the study per protocol after the 1-year visit.

Interim Analysis. ‌ An interim data analysis designed to evaluate effectiveness for continuing crossover of control Control arm study participants after the 1 year follow-up visit to EBV treatment will be performed when 74 (50% of the required minimum of 147) study participants have completed the 1 year follow-up. If crossover of control Control arm study participants is found to be justified by the interim analysis then crossover of a control Control arm study participant participants after (s)/he s)he has reached the 1 1-year follow-up time point may be continued. The results of the interim analysis will be reviewed by the DSMB and FDA. If the DSMB recommends not continuing crossing control arm participants to EBV treatment treatment, then those control arm participants who have not crossed over will exit from the study per protocol after the 1-year visit.