12: Insights from Data Monitoring Committee Meeting Closed Sessions: Case Studies of Concerns, Resulting Recommendations, and Follow-up Over Time

Music City Center 

Data monitoring committees (DMCs) review ongoing clinical trial data to make recommendations regarding trial conduct based on risk-benefit. The objective of this poster is to provide case studies of example situations that arose from a DMC's statistical review of unblinded by-arm data that led to concerns, how the DMC made recommendations based on the situations, and the subsequent actions that were taken to ensure patient safety and trial integrity. In many instances, DMCs recommend trials continue without modification as there are no concerns or the concerns do not rise to an actionable threshold. However, if a concern rises to an actionable level, the background for the actions is motivated by by-arm data and is not available to sponsors to protect trial integrity and minimize the potential for bias. These case studies will describe example concerns that can arise based on unblinded data, how a DMC may arrive at their recommendation and action items, and how the follow-up over time addresses the underlying concern.