Medtronic/rhBMP-2

Medtronic Collaboration

The Yale University Open Data Access (YODA) Project is pleased to announce an important milestone in its first initiative, a novel partnership with Medtronic, Inc. to study and release all of the company’s clinical research data related to recombinant human bone morphogenetic protein-2 (rhBMP-2). Medtronic, Inc. provided a grant to Yale University to apply the YODA Project model in practice for the first time. Yale led independent, systematic reviews of the entire body of scientific evidence regarding the safety and effectiveness of Medtronic’s rhBMP-2 product. The reviews were conducted independently by two academic teams with full access to all Medtronic’s clinical trial, post-marketing and safety data about rhBMP-2. In addition, the grant supports the dissemination of all Medtronic clinical research data on rhBMP-2 to external investigators.

Please follow the links on this page to access the following:

  • Results of independent reviews of rhBMP-2 published in the June 18 issue of Annals of Internal Medicine
  • Full comprehensive reports written by the review organizations
  • Medtronic's rhBMP-2 dataset available free of charge to approved investigators who wish to create generalizable scientific knowledge

Data Release Policy

Yale University developed a Data Release Policy to govern access to Medtronic’s rhBMP-2 data.

Click here for the policy

This policy was informed by the following:

  • Recommendations from the YODA Project Steering Committee and other independent experts (made in the context of a conference hosted by Yale University in June 2012);
  • Additional communications with these experts and others;
  • Comments received during a public comment period; and
  • The YODA Project team’s review of the literature and policies from other bodies engaged in clinical trial data sharing.

We expect the process by which we finalize the policy for data release to be iterative and informed by on-going experiences with data requesters and users.