DMC Vs EAC: What's the Difference?

By James Riddle, Vice President of Research Services & Strategic Consulting

Clinical trials can be complex. Multiple treatments arms, various dosing schedules and regimens, placebo controls, multifaceted endpoints, blinded study staff, pragmatic design elements, and multinational sites all fuel the complexity. In its March 2006 guidance Establishment and Operations of Clinical Trial Data Monitoring Committees, the U.S. Food and Drug Administration (FDA) solidified the need for sponsors to consider establishing independent committees to oversee certain aspects of clinical trials.

Around the same time, the terminology of data monitoring committee (DMC) and endpoint adjudication committee (EAC) started to infiltrate the clinical trial world. These committees had been around prior to guidance, but the March 2006 FDA guidance and similar guidance in July 2005 from the European Medicines Agency (EMA) solidified the need for these two groups. Over fifteen years later, most involved in clinical research have at least heard of EACs and DMCs, also known as clinical event committees (CECs) and data safety monitoring boards (DSMBs), respectively.