Interim analysis results are reviewed
The Data and Safety Monitoring Board (DSMB) reviews the results of the interim analysis. This is a critical juncture in the conduct of any clinical trial as the DSMB may recommend that the trial be stopped for futility, safety concerns or unexpected benefit. Not surprisingly, the D2d team is nervous. The DSMB reviews the data (when 70% of the total required number of diabetes have occurred) and recommends that the D2d study proceed to completion as planned. This is a good sign. The D2d team is very pleased and excited to continue its work.