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Abstract:
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Interim safety monitoring by Data Safety Monitoring Boards (DSMBs) or Data Monitoring Committees (DMCs) is an integral part of the clinical development of many new therapies. Preparing and delivering DSMB reports can be time-consuming, especially in complex clinical trial settings, and the process is further complicated by the long list of stakeholders with conflicting demands. Accuracy and speed – and potential trade-offs between the two – are always critical considerations. Modern approaches and tools (e.g., CDISC data standards, electronic data capture, and real-time monitoring) have increased the speed and accuracy of data acquisition and have facilitated efficient downstream use. As a result of these standards and technologies, stakeholders have increased expectations about how quickly interim data can be cut and analyzed and the materials made available to the DSMB. This panel will discuss what changes have become the norm in DSMB report preparation and what challenges still persist. In particular, we will focus on what factors must be brought to stakeholders’ attention to help them understand why it will not “just take a push of the button” from database lock to DSMB me
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