Data Safety Monitoring Board (DSMB)
An independent committee of experts that monitors patient safety and treatment efficacy during a clinical trial. The DSMB reviews unblinded interim data and can recommend stopping a trial early if the treatment shows clear benefit, clear harm, or futility.
Technical Context
DSMBs (also called Data Monitoring Committees, DMCs) typically include: clinical experts in the disease area, at least one biostatistician, and sometimes an ethicist. DSMB members must be independent of the sponsor and investigators. They review unblinded data (the only people permitted to see treatment assignments during the trial) at pre-specified interim analyses. DSMB actions include: continue as planned, modify the protocol, temporarily halt enrolment, or permanently stop the trial (for overwhelming benefit — ethical to make treatment available sooner; for safety — unacceptable harm; or for futility — treatment unlikely to show benefit even if continued). DSMB deliberations are confidential. The DSMB charter defines operating procedures, interim analysis timing, and statistical stopping boundaries.