The Importance Of Keeping DSMBs Independent

By James Riddle, Vice President of Research Services & Strategic Consulting, and Barbara Schneider, Executive Director of Biostatistical Services

When conducting research, in some cases sponsors and contract research organizations (CROs) may involve a data safety monitoring board (DSMB), also referred to in regulatory documentation as a data monitoring committee (DMC). Per US Food and Drug Administration (FDA) guidance, DSMBs are supposed to be independent of the party who is conducting the research. This blog outlines when a sponsor or CRO can enlist a DSMB’s help, and why DSMB independence is critical to a successful study.