Within-Trial Decisions

4. Data Safety Monitoring Boards (DSMB)

Data safety monitoring boards (DSMB) also go under different names like Data Monitoring Committee (DMC), Data Monitoring Board or Data Safety Monitoring Committee. EU legislation uses the term DMC, but EUPATI will use the term DSMB based on the frequency of use seen, even if the original document used a different term.

A DSMB is a group of independent experts external to a study assessing the progress, safety data and, if needed critical efficacy endpoints of a clinical study. In order to do so a DSMB may review unblinded study information (on a patient level or treatment group level) during the conduct of the study. Based on its review the DSMB provides the sponsor with recommendations regarding study modification, continuation or termination. (1)

A DSMB may be set up for different reasons, here are some:
  • In case of life-threatening diseases from an ethical point of view.
  • In case of long-term trials even in non-life-threatening diseases for monitoring safety.
  • In case of prior knowledge or strong suspicion that a treatment under consideration has the potential to harm patients.
In case of a specific study design, e.g. in the context of pre-planned interim analyses for early stopping (either for futility or for positive efficacy) or in case of complex study designs where a possible modification of the study design based on unblinded interim data is intended.