Evaluating patient data to ensure the continued safety of clinical trial subjects is an important part of a sponsor’s responsibility. Sponsors often enlist the help of independent boards to ensure expert oversight and eliminate the potential for bias.
The two primary groups that could be used are data safety monitoring boards or data monitoring committees (DSMB or DMC) and clinical events committees (CEC). The use of these boards may be required, but in most cases, the decision to use them is open to interpretation.
Does your trial need a DSMB, CEC or both? Click below to view our latest infographic with guidelines to consider as you plan your trial.