Data Monitoring, Endpoint Adjudication on the Rise in Clinical Trial Landscape

James Riddle, MCSE, CIP, CPIA, CRQM, Vice President, Research Services & Strategic Consulting, Advarra

A combination of regulatory incentives and sponsor interest has raised the profile of independent data monitoring committees (DMCs) and endpoint adjudication committees (EACs) in the clinical trial landscape over the past several years, says James Riddle, BA, CRQM, CPIA, CIP, vice president for research services and strategic consulting with Advarra.

While the U.S. Food and Drug Administration and European Medicines Agency have issued guidances to encourage usage of such committees, sponsors also increasingly want to include independent “voices” to vet data, Riddle says. DMCs and EACs have definitely “seen an upward trajectory over the last five to seven years,” he notes.

While representatives from sponsors interact far more often with DMCs and EACs than most other members of clinical trial teams ever do, Riddle notes it’s important for all practitioners to have a better understanding of the broader clinical research enterprise, including details on where the data go after input and how they are reviewed.

Staff at study sites and others should “appreciate that other independent groups [aside from institutional review boards] are overseeing data they produce,” Riddle says.

Webinar: Understanding the Role of DMCs and EACs in Research Oversight

Free for ACRP Members! Join Riddle for this June 15 webinar as he delves into the role and function of DMCs and EACs. Learn about U.S. and European guidelines governing when DMCs and EACs should be considered for clinical trials, understand their roles and how their oversight differs from the Institutional Review Board, and more.

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Awareness might also present some with new career options, Riddle adds. For example, a study coordinator who enjoys statistics and numbers but is burned out on patient engagement might find work with a DMC or EAC an interesting avenue to pursue. He says they could first volunteer to serve on a committee, in part to learn more about the industry and explore it for themselves professionally. Many large academic medical centers have their own in-house committees where there might be opportunities to participate, he adds.

It will make a clinical trial professional stronger if he or she better understands how “other parts of clinical research fit together,” Riddle notes.

Author: Michael Causey