Data and Safety Monitoring Boards in Clinical Trials

Data and Safety monitoring Boards (DSMB), also called Data Monitoring Committees (DMC) or Data and Safety Monitoring Committees (DSMCs), are independent committees of experts used to review summary safety data at regular intervals during clinical trials to detect early safety signals and avoid unnecessary risk for participants.

By definition, there are many unknowns at the time of the conduct of a clinical trial, even at the late stages (Phase III). In particular, it is not always known whether a new drug may cause side effects that are rare enough to have evaded detection in earlier phases. To prevent participating patients from being exposed to unnecessary risks, it is advisable to review safety, and occasionally efficacy data and determine whether the benefit/risk ratio remains acceptable.  Based on this review, the DSMB or DMC committee will be able to assess if the study can continue, if modifications to the protocol are needed or if the study should be terminated. 

Why is DSMB review important?

One of the pillars of good science is to avoid bias due to the observer’s knowledge, preconceptions, fears etc. Clinical study teams are therefore prevented from knowing the actual treatment received by each individual patient (blinded studies) or from reviewing summary data and statistical results (open label studies) until the clinical database is locked. Until such time, the clinical team concentrates on collecting and verifying all necessary data from the investigational sites, remaining as neutral as possible. As a result, it is not possible for the study team to review summary safety data during the study unless an interim analysis is planned in the protocol.

A DSMB is a panel of experts not otherwise involved in the study and having no financial or non-financial interest in the drug under study. As such, these experts are considered neutral and may be presented with the summary and detailed data under stringent conditions of confidentiality. They can then issue a recommendation to the study sponsor. 
DSMBs meet at predefined intervals to review data prepared and explained by an independent statistician, discuss, and emit opinions and recommendations. These meetings may occur in person or in a teleconference.