Amarin Corp Plc (AMRN)

[HDGabor]

Thanks JL, it was a good find.

The IDMC usually consists of international clinical research experts, together with representatives of the sponsor and a medical statistician to provide results to the IDMC based on statistical analyses of accumulated data from all sites.

In a standard trial, safety and efficacy data are collected and reviewed by a data safety and monitoring committee during scheduled interim analyses.

Establishment of a DSMC: In life-threatening disease trials it is common to have a DSMC in the first instance from an ethical point of view. Apart from ethical and safety concerns, there are other factors that bring about the establishment of a DSMC, including the need for early stopping at the pre-planned interim analyses or need for modification to the trial design based on unblinded interim data analysis for adaptive trial designs, which tend to be more complex