FDA: Risk-Based Monitoring Remains Fuzzy Concept in Clinical Trials Industry

Risk-based monitoring (RBM) has become a confusing buzzword that too often means different things to different people. That’s a potentially dangerous situation, says David Burrow, acting deputy director of the Office of Compliance for the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER). “RBM should be one part of a larger system that starts with risk assessment before even putting together a study protocol,” he warns.

RBM must be factored in when deciding what types of data will be collected and what needs to be in a protocol. The protocol, in turn, becomes a “blueprint for quality” that then allows trials to use RBM in a narrowly targeted way that is thought through from the outset—not as something grafted onto an already ongoing trial. Trial personnel must understand the entire lifecycle of the trial from the very beginning, Burrow stresses.

Before RBM can leap forward as a ubiquitous tool, FDA needs to see industry examples of a complete lifecycle trial using it. That’s a bit of a catch-22, Burrow concedes, because that complete lifecycle can take several years. “We haven’t yet seen one with RBM fully in place from day one,” he says. Sites have been using RBM principals in the intermediate portion of trial development, but that’s not enough for the FDA to weigh in conclusively.

“It’s appropriate to have a continued discussion with ACRP members” to swap RBM case studies, lessons learned, and best practices, Burrow says. He will speak at ACRP’s upcoming Meeting & Expo in Atlanta, Ga., offering advice on how best to handle an overall FDA inspection, and encouraging attendees to help the agency further advance its RBM policies by sharing their experiences with RBM on the front lines of clinical trials.