Data and Safety Monitoring Boards

Data and safety monitoring has become an integral part clinical research studies. It plays important roles in reviewing accumulating data. Their primary function is ensuring the safety of the trial participants. They also help ensure study integrity. Consequently, the concept of the data and safety monitoring board (DSMB) was developed. The DSMBs uses numerous statistical and non-statistical approaches. The DSMB typically gets two types of reports to review. One involves process, the other outcome. Many issues, such as, repeated testing for statistical significance, asymmetry in data monitoring, and use of external information, are of particular concern in data monitoring. There is no substitute for the discussions that consider these complex issues.

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