Medtronic – Overview
The YODA Project seeks to address the problem of unpublished and selectively published clinical trial research. Medtronic was the first company to contract with the YODA Project to allow access to all of its clinical trial data for independent reanalysis, a tremendous step forward in the emerging era of open science.
As part of this initiative, the YODA Project first contracted with two independent research groups that were competitively selected to review and meta-analyze all clinical studies of Medtronic’s rhBMP-2. The Oregon Evidence-based Practice Center at Oregon Health & Science University (OHSU) in Portland, Oregon, and the Centre for Reviews and Dissemination at the University of York, United Kingdom, were selected. More information about these outstanding research groups can be found here.
With the publication of their independent, peer-reviewed reviews and meta-analyses, both as comprehensive reports and in the Annals of Internal Medicine, Medtronic’s rhBMP-2 clinical trial data were made available to other investigators who wished to pursue scientific research, either to address unanswered questions or to reproduce the work conducted by OHSU and York. These data were available for investigators to request from June 2013-June 2015.
This initiative was an important step toward more open science, whereby industry, investigators, and regulators pursue more transparent and collaborative pathways of clinical trial research, ensuring that patients and physicians have the best possible understanding of medical product effectiveness and safety.