By James Riddle, Vice President of Research Services & Strategic Consulting
Clinical trials can be complex. Multiple treatment arms, various dosing schedules and regimens, placebo controls, multifaceted endpoints, blinded study staff, pragmatic design elements, and multinational sites all fuel the complexity. Not surprisingly, clinical trials receive a lot of oversight from regulatory agencies as well as independent committees, who oversee different aspects of the trial. Institutional review boards (IRB), also known outside the US as research ethics boards (REB), ethics committees (EC), or independent ethics committees (IEC), are likely the most well-known of the independent oversight committee functions. (For the sake of simplicity, in this article we’ll refer to this committee as an IRB.)
In this blog we will take a look at the specific role DMCs play in overseeing research, and how IRBs rely on the independent DMC’s oversight of interim trial data to ensure an adequate safety monitoring plan is in place.