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

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David Burrow, acting deputy director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research

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.

Learn more about Burrow’s ACRP 2016 Meeting & Expo sessions:

One thought on “FDA: Risk-Based Monitoring Remains Fuzzy Concept in Clinical Trials Industry

  1. Myron,

    While I don’t think this blog is helpful for the newsletter, when you open up the blog, there is a list of archived blogs which might yield useful topics. Jo

    *JoAnn Filla-Taylor BSN, RN, CCRC* *Clinical Trials Coordinator* *Saint Louis University* *Salus Center, 2nd Floor, Rm. 2372* *3545 Lafayette Avenue* *St. Louis, MO 63104-1314* *Phone: 314-977-7525* *Fax: 314-977-4080*

    The materials in this message are private and may contain Protected Healthcare Information or other information of a sensitive nature. If you are not the intended recipient, be advised that any unauthorized use, disclosure, copying or the taking of any action in reliance on the contents of this information is strictly prohibited. If you have received this email in error, please immediately notify the sender via telephone or return mail.

    On Thu, Feb 18, 2016 at 7:30 AM, ACRP Blog wrote:

    > ACRP posted: ” 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 ” >

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