Medtronic has provided a $2.5m grant to Yale University to conduct two fully independent, third-party systematic reviews to assess the safety and effectiveness of Infuse Bone Graft, a 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.
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Yale with all available patient-level data on rhBMP-2 from Medtronic-sponsored clinical trials, both published and unpublished, as well as all FDA-filed adverse event reports.
The company will voluntarily make all of its clinical-trial results information on the product available publicly on ClinicalTrials.gov.
Harlan Krumholz of Yale School of Medicine will assemble a steering committee of 12 to 15 advisors including those with expertise in clinical issues, clinical reviews, clinical trial conduct, systematic reviews, statistical analysis of clinical trial program data and ethical standards related to conflicts of interest, as well as a consumer representative.
Two organizations with significant expertise in conducting large systematic reviews will evaluate the data independently.
Yale will expedite the reviews and seek to complete them within six months, and plans to make the data available within 18 months.