Independant Data Monitoring Committee


The IDMC is responsible for safeguarding the interests of trial patients, monitoring the accumulating data and making recommendations to the TSC on whether the trial should continue as planned.

The Independent Data Monitoring Committee (IDMC) is the only oversight body that has access to un-blinded accumulating comparative data. The role of the IDMC is to assess at intervals, the progress of the trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop the trial.