DSMB
Also written as: DSMB — Data Safety Monitoring Board
An independent committee that monitors clinical trial safety data and makes recommendations regarding trial continuation, modification, or termination.
Full Definition
A Data Safety Monitoring Board (DSMB) is an independent group of experts in clinical research, biostatistics, and the relevant medical specialty who review unblinded safety and efficacy data during clinical trials. The DSMB operates independently from the study sponsor and investigators to ensure participant safety and study integrity. Members assess adverse events, interim efficacy data, and overall risk-benefit ratios to make recommendations about study continuation, protocol modifications, or early termination. In cardiovascular research, DSMBs are particularly important given the life-threatening nature of many cardiac conditions and interventions.
Usage
Usage note: Use 'DSMB' in clinical contexts; 'DMC' is acceptable alternative but maintain consistency within documents.
In Context
- "The DSMB conducted scheduled interim safety reviews every 500 enrolled patients." — Clinical trial protocol
- "Following DSMB recommendations, the study protocol was amended to include additional safety monitoring." — Protocol amendment