Establishing And Operating A DSMB

Data safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), serve a critical role in clinical research by detecting early evidence of benefit or harm while maintaining data integrity and validity. Guidance from the Food and Drug Administration (FDA) and European Medicines Agency (EMA) recommends the DSMB be completely independent of those sponsoring, organizing, or conducting the clinical trial. This white paper discusses the DSMB’s role in research, the basics of setting up a DSMB, and why independence is so important.

Ultimately, review boards such as the DSMB are established to ensure high-caliber research is conducted and participants’ welfare and safety are at the forefront. Maintaining independence between these review boards and sponsors/CROs not only ensures research validity, but also eliminates bias as research is conducted.