Setting up and managing a DSMB is a complex and lengthy process. Let alone managing several of these committees in a large organization. Because of the sensitive nature of such committees, specific SOPs are usually created, and dedicated charters prepared and agreed by all parties. Making sure to follow all the necessary rules, sometimes for years, is not easy. A well-set software tool can greatly help harmonize, follow, respect, and report the committees work – in other words ensure the process governance – and thus support overall quality in clinical studies.
Randomized, double-blind clinical studies have become the standard in drug development for decades. Why? Because this setup best guarantees an unbiased comparison of a new drug, either to placebo or to another active treatment. But randomized, double-blind studies come with a cost. Neither the sponsor, nor the investigators can know if the drug works or if there could be undetected risks to the participants. A DSMB, or DMC is an independent committee of experts, unrelated to the sponsor, the drug or the study whose task is to review unblinded aggregate data during the course of the study and advise on changes or even mandate to stop the study if they detect a signal related to safety and occasionally to efficacy. The use of DSMBs has become widespread in recent years as a means to ensure that participants to clinical studies are not exposed to unnecessary risk, especially for life-threatening pathologies or during lengthy studies.The GCP, SOP and committee charter constraints
DSMB activities are subject to several regulations including GCP and are therefore governed by specific SOPs that the sponsor must prepare and validate. SMB members must be aware of these SOPs as part of their training and qualification. In addition, specific rules are detailed in the DSMB charter including the projected process for data review, reporting and actions taken. Harmonizing and following the correct rules in DSMB management, in other words following good process governance can be complex and difficult to follow especially in long studies where personnel may change and where DSMB operations can be separated by long periods of time. Needless to say, when an organization such as a pharmaceutical company, a CRO or an ARO is managing several such committees, things can only get harder!eDSMB® for process governance optimization
The solution can come from a validated software platform such as eDSMB® where the different rules applicable to DSMBs can be embedded at different levels, thus ensuring that they are respected regardless of who or when is called to perform the different process steps. Using the same tool for all DSMBs in an organization guarantees that the same rules are uniformly applied while specific provisions for each study are also planned and followed. Finally, recording and documenting actions and decisions is paramount to the overall quality of a study; software platforms effortlessly perform these steps and prepare archive-ready records for the TMF and for future inspections.
In summary, good governance leads to good results and a software platform that supports the DSMB process governance will be a definite asset for any organization involved in drug development.
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A single, integrated handbook regrouping various sources of information on when, why and how to set up and use DSMBs and DMCs.
