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Medtronic engages Yale University to oversee independent reviews of recombinant bone morphogenic protein-2
Medtronic Inc. announced that it has provided a grant to Yale University to conduct two fully independent, third-party systematic reviews of the safety and effectiveness of its recombinant bone morphogenic protein-2 (rhBMP-2) product, which stimulates bone formation.
According to a company press release, Medtronic will provide Yale with all available patient-level data on rhBMP-2 from Medtronic-sponsored clinical trials, both published and unpublished, as well as all FDA-filed adverse event reports, for the purpose of executing an independent and comprehensive review of the entire body of evidence. Yale will assemble a panel of experts and will commission two clinical research organizations specializing in systematic reviews to conduct the analyses.
“Our pledge to support full access to the clinical data, in the form of independent patient-level data for the systematic reviews, retroactive registration of all trials with the National Library of Medicine, and the provision for broad investigator access of all patient-level data from Medtronic-sponsored studies, represents a novel and significant commitment to transparency and open-access scientific research,” Medtronic chief scientific officer Rick Kuntz, MD, stated in the release.