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. 

The Challenge of Managing a Data and Safety Monitoring Board

The first step is to identify the DSMB members and verify their expertise and independence. Once the experts are recruited, the Committee Charter can be finalized, and the kick-off meeting can take place. At each subsequent meeting of the DSMB, blinded and sometimes unblinded data is presented that will allow the experts to detect potential safety signals and decide on the continuation of the study. The sponsor is required to act accordingly and document all actions.

eReconciliation for SAE Reconciliation

Data Monitoring Committees and Data Safety Monitoring Boards Terms Glossary

Data Monitoring Committees (DMC) and Data Safety Monitoring Boards (DSMB) Definitions, Procedures and Tools.

eReconciliation for SAE Reconciliation

FDA/EMA Guidance about Data Safety Monitoring Boards

Establishment and Operation of clinical trial Data Monitoring Committees and Data Safety Monitoring Boards – Helpful links to the FDA and EMA Guidance Documents.

Download Ethical eReconciliation for SAE Reconciliation Dossier

The DSMB-DMC Complete Handbook

A single, integrated handbook regrouping various sources of information on when, why and how to set up and use DSMBs and DMCs.