Keywords: DMC, DSMB, SDAC, interim, futility, efficacy
Data Monitoring Committees (DMCs) are an important component of the clinical trial process. They are charged with reviewing interim data and making recommendations to protect the safety of trial participants and ensure the scientific integrity of the study. This roundtable will discuss how all participants in the DMC process – the DMC members, the sponsor team and the Statistical Data Analysis Center (SDAC) supporting the DMC - can employ best practices as enumerated by regulatory guidance and the recent CTTI white paper. Specific topics to be discussed will include current guidance documents; the organizational flow of the DMC process and the responsibilities of those involved; DMC meeting structure, timing, and purpose; logistics of DMC membership including assessment of conflict of interest; DMC review of study conduct, safety, efficacy (possibly with formal boundaries); closed session interaction between the SDAC and DMC; hallmarks of a good SDAC; DMC recommendations including considerations for recommending premature termination of the study or alternatives; and examples of “tricky situations” and how to deal with them.