New FDA guidance on clinical trials inconsistent with international standards

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FDA released a draft guidance document titled "Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring," in In August 2011. According to clinical trials expert Nancy Stark, "The draft guidance is based on the premise that most sponsors conduct on-site monitoring visits every 6-8 weeks with the goal of source verifying 100% of the data 100% for 100% of the subjects. It uses this premise to argue that sponsors will save money by moving to risk-based monitoring because such a move will result in fewer monitoring visits." Stark is owner and president of Clinical Device Group.

Stark says that at first she was "very excited because the monitoring guidelines had not been updated since the 1988 "Monitoring of Clinical Investigations. But then, as I began to consider the ramifications of implementing the new guidance for medical device investigations, I started to have mixed feelings."

Stark has written a white paper, titled "Risk-Based Monitoring--The New FDA Guidance" exploring the implications of the guidance. She has also prepared a two-hour recorded training on the guidance. The first part of the paper is a factual review of the draft guidance with ideas about how device manufacturers can take advantage of it. In the the second part, she expresses her views about what the guidance will mean for the device industry.

"The guidance flies in the face of the new international standard ISO 14155 "Clinical investigations of medical devices in human subjects—good clinical practices" (2011) and is only marginally consistent with ICH-GCPs," Stark says. She asks: Why is FDA encouraging such a radical and cardinal shift in our approach to study management? Will we, once again, have to rewrite our quality management systems for clinical investigations? Is there a career future for monitors? And most importantly, how can device firms leverage the new guidance to reduce monitoring costs?

She says that the draft guidance, which repeals the 1988 guidance, "leaves a framework vacuum in its wake." It references the 15-year-old ICH-GCPs (written in 1996 by pharmaceutical sponsors and regulators from the US, Europe, and Japan) six times. It is "showing a few signs of age—there is no discussion of central data management or electronic security issues, for example." She reviews some other trouble spots, including that the draft guidance draws heavily on the ever-increasing presence of electronic data collection and that the Offices of Compliance from CDRH, CDER, and CBER who wrote this guidance. "While they promise us the inspection manual will be promptly updated to match the guidance, they do not make assurances that the reviewers in the Office of Device Evaluation will follow along. Sponsors are strongly urged to get buy-in on the monitoring plan from reviewers before initiating a clinical trial."

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