Data Safety Monitoring Boards
CHMP Guidelines define a Data Monitoring Committee as "a group of independent experts external to a study assessing the progress, safety data and, if needed critical efficacy endpoints of a clinical study. In order to do so a DMC may review unblinded study information (on a patient level or treatment group level) during the conduct of the study. Based on its review the DMC provides the sponsor with recommendations regarding study modification, continuation or termination".
It can be seen that the DMC (or Data Safety Monitoring Board) is an important safeguard for patients and clinical trial sponsors alike. However, it is vital that the board should include people who understand and have experience with clinical trial safety overall, not only experts in particular therapeutic areas or with specific types of drug. PrimeVigilance consultants have been involved in setting up, chairing and sitting on DMCs in a variety of therapeutic areas1. They can help strike the balance between over-anxiety about findings that are perhaps not of major importance and the failure to detect signals through lack of experience with this type of data. Experienced consultants can also help to ensure that the DMC sticks to the remit established in its charter and does not stray into areas that may not be relevant.
1. Data Monitoring Committees in Paediatric Research. van den Ouweland F, Brown EG, Carr DJ. Paediatr Perinat Drug Ther, 2004; 6 (2)
PrimeVigilance: Monitoring data, protecting patients and products
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