Data monitoring committee

Blinding is breached and true assignments disclosed only after the trial database is finalized and locked against edits (i.e., until it is read only for statistical analysis).

Clinical trials may test an unknown procedure or may continue for years, and there is justifiable concern about enrolling participants and exposing them to an unproven treatment without ongoing oversight of the preliminary results.

The DMC will convene at predetermined intervals (depending on the type of study) to review unblinded results.

There are typically three reasons a DMC might recommend termination of the study: safety concerns, outstanding benefit, and futility.

It is extremely unlikely that the trial, should it continue to its planned end (which could take months or years to reach, based on, particularly, rate of accrual), would have the statistical evidence needed to convince a regulatory agency to approve the treatment.