Data & Safety Monitoring Board (DSMB)

The purpose of the DSMB is to provide oversight for the FAST Therapy Trial, assessing the safety and efficacy of study procedures, and for monitoring the overall conduct of the randomized clinical trials (RCTs). The board is responsible for assessing the progress of the trial, the safety data and critical efficacy variables to preserve the integrity of the study and to protect the rights and welfare of the study participants. The DSMB will review interim data on patient recruitment, trial outcomes, and safety data in order to make recommendations to the sponsor Dr. Jaeggi and the trial Steering Committee.