A DSMB is a group of experts formed outside of the pharmaceutical company or CRO commissioning or conducting a particular clinical trial. The aim of the DSMB is to provide impartial safety advice, often in the context of benefit and risk. 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”.
Under clinical trial conditions patients tend to be monitored far more closely than would be the case in day-to-day medicine. Consequently issues will be picked up earlier than in standard spontaneous reporting pharmacovigilance. However this close monitoring does lead to adverse events being reported that are not caused by the trial drug. Under normal clinical conditions on the other hand, adverse reactions are vastly under-reported. DSMBs are not compulsory in clinical trials and their use depends on the nature of the drug being trialled, the condition being treated, length of trial, number of patients and a host of other factors. A DSMB may be just one of several teams with oversight of clinical trials. The EU expects DSMBs to be appointed if, for example, there are potential safety concerns or potentially life-threatening reactions and publishes guidelines on how a DMC should be appointed, what its responsibilities would be and how it would operate.
The need for a DMC should generally be discussed during the planning of any clinical trial programme. They would be expected to have been formed in all trials involving a life-threatening disease and are also a consideration when trials involve certain groups within the population, for example, children, the elderly, people who are pregnant. DMCs are a consideration when there is a suspicion the treatment has the potential for higher levels of risk of harm, for complex trial designs and where there is a probability that study modifications may be needed.
A DMC is likely to take at least several weeks of valuable time to set up.
DMCs are an important safeguard for patients and clinical trial sponsors alike. It is vital that the board is formed from those who understand and have experience with clinical trial safety overall, not just experts in particular therapeutic areas or with specific types of drug. PrimeVigilance and its consultants have been involved in setting up, chairing and sitting on DMCs in a variety of therapeutic areas. 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. Involving experienced pharmacovigilance 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.
For more information contact PrimeVigilance today
Committee for Medicinal Products For Human Use Guideline EMEA/CHMP/EWP/5872/03 of 27th July 2005 on Data Monitoring Committees. European Medicines Agency.
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