Should a complex clinical trial be stopped, i.e. due to the accumulation of unexpected serious adverse reactions, or even missing or surpassing effectivity of the medicine? These are some of the questions the Data Safety Monitoring Board, shortly known as DSMB or DCM (Data Monitoring Committee) has to decide upon.
The institution of a DSMB is recommended in clinical trials concerning especially life- threatening indications, concerning long-term therapies or those therapies with substances that yield more or graver side effects; above all a DSMB is strongly recommended when groups of patients are concerned that are subject to more restrictive legal or ethical concerns and/or protection.
The DSMB is an independent committee, consisting of experienced medical personnel, which has expertise in biostatic as well as basic ethical questions. They review the documentation of interim analyses and decide about questions of patient security, risk –benefit analysis and effectiveness of the substance.
The DSMB is only eligible to give advice to the sponsor – the responsibility for the trial always rests with the sponsor.
(Weidenthaler, Dr. Heinz, “Data Safety Monitoring Board-unabhängige Instanz für die Patientensicherheit“” published in Pharmazeutische Medizin 2011 Heft 3, Jahrgang 13; excerpt)