High-risk of issues in high-risk device trials, say researchers

By Melissa Fassbender contact

- Last updated on GMT

(Image: iStock/Sean_Kuma)
(Image: iStock/Sean_Kuma)
Clinical trials supporting changes to high-risk medical devices often lack quality data, according to a recent report.

Researchers at the UC San Francisco (UCSF) and Yale School of Medicine reviewed clinical trials supporting US Food and Drug Administration (FDA) approval of changes to high-risk medical devices.

According to the study, which was recently published​ in Journal of the American Medical Association (JAMA), fewer than half of the studies were randomized, blinded, or controlled – failing to meet the so-called "gold standard" for clinical research.

"These findings suggest that the quality of studies and data evaluated to support approval by the FDA of modifications of high-risk devices should be improved​," the researchers said.

The researchers examined 83 clinical studies for 78 panel-track supplements approved between 2006 and 2015. According to the report, 45% were randomized clinical trials and 30% were blinded.

A panel-track supplement​ is submitted “for a change in indication for use or a change to (or removal of) a contraindication of the device​,” according to the FDA.

Rita Redberg, MD, MSc, a professor of medicine at UCSF and the study's senior author said there is a lot of pressure on the FDA to move quickly to bring treatments to the market. "But you don't know if they're innovative or life-changing until you've done a careful study​. These were short studies, with low-quality data, and little follow-up after approval​," she said.

An FDA spokesperson told us the agency is aware of the study and will carefully consider its findings.

Industry response

The authors highlight an important topic; one that cannot be ignored given it has patient safety at the core​,” said Kim Michelson, vice president, clinical operations, clinical trial management at Medpace.

Device studies do have unique challenges associated with blinding and long-term patient follow-up but there are customized solutions that can be built to address these important design and operational needs​,” she told Outsourcing-Pharma.com.

Rigorous and disciplined planning and execution not only protects patient safety, but it can be leveraged by sponsors for long-term success​,” Michelson added.

Source: JAMA
doi:10.1001/jama.2017.9414
Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements
Authors: Sarah Y. Zheng, MD1; Sanket S. Dhruva, MD, MHS2,3; Rita F. Redberg, MD, MSc4

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