Recently there’s been an influx of companies sharing their views on the importance of Data Monitoring Committees (DMCs) and the roles they share with Endpoint Adjudication Committees (EACs).
For example, one company recently published a whitepaper with the viewpoint that a DMC and EAC should share opinions in a clinical trial. They go on to say that an EAC will have preference in interpreting a trial’s endpoints, however a DMC can share their viewpoint of the trial and convince the EAC to change their opinion.
At ACI Clinical, we stress the importance of maintaining a firewall between DMCs and EACs once study activities are taking place. However, we have found that it is quite helpful to facilitate a discussion during the startup-up period if possible so that the DMC, or at least the DMC Chair, is aware of the EAC process and what the EAC is chartered to do. This understanding can help the DMC to have a better perspective of the aggregate data that they review, especially with respect to the adjudicated data.
When managing both Endpoint Adjudication Committees and Data Monitoring Committees for clients, ACI Clinical ensures the appropriate separation between project teams and committee members to avoid any perception of bias in the study data.
Contact us today to learn more how we support DMCs and EACs.