Yale University will conduct two fully independent, third-party systematic reviews on the safety and effectiveness of Medtronic’s Infuse recombinant bone morphogenic protein-2 (rhBMP-2) product, which stimulates bone formation.
Medtronic will sponsor Yale with US $2.5 million to cover the costs of the analysis, oversight and operations of the systematic reviews and data management programme. Yale will assemble a panel of experts and will commission two academically recognised, publicly trusted clinical research organisations specialising in systematic reviews to conduct the analyses and ensure the findings are reproducible and of the highest integrity. Yale will expedite the reviews and seek to complete them within six months, and plans to make the data available within 18 months.
Medtronic will also 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Yale with all available patient-level data on rhBMP-2 from Medtronic-sponsored clinical trials, both published and unpublished, as well as all FDA-filed adverse event reports, for the purpose of executing an independent and comprehensive review of the entire body of evidence.
In addition, Medtronic will voluntarily make all of its clinical-trial results information on the product available publicly on ClinicalTrials.gov, the clinical-trial registry managed by the National Library of Medicine.
Finally, Medtronic has agreed with Yale to develop a novel programme to provide researchers access to all data on rhBMP-2 by means of a defined registration process and website. This planned programme is unprecedented in the medical industry, and will differ from clinical trial publications or other data sources in that it will provide access to the full patient-level data sets possessed by Medtronic, including independent de-identified patient level data, not just the data summaries that are commonly used in meta-analysis and systematic reviews.
“We understand questions have been recently raised about rhBMP-2 and look forward to sharing our conclusions publicly on the safety and effectiveness of this product at the end of our reviews of a full set of patient-level product data,” said Harlan Krumholz, Harold H Hines Jr. professor of Internal Medicine, Epidemiology and Public Health at Yale School of Medicine. “This project, including making the data accessible to all researchers, is intended to establish a landmark model for data transparency – a breakthrough in balancing the needs of industry with the public’s desire for an independent review of the complete set of data. If successful, this new approach can become standard practice. Medtronic is taking an important leadership position that we hope others will follow.”
Rick Kuntz, Medtronic’s chief scientific officer, said, “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.”
Infuse bone graft is recombinant human bone morphogenic protein-2 (rhBMP-2) applied to an absorbable collagen sponge carrier. The purpose of the protein, which occurs naturally in the body, is to stimulate bone formation. The first FDA approval was received in 2002 and the product has been approved by the FDA for three indications.