Yale University Open Data Access (YODA) Project: A New Approach to Evaluation and Transparency

Each day, patients and their physicians make treatment decisions with access to only a fraction of the relevant clinical research data. Many clinical studies, including randomized clinical trials, are never published in the biomedical literature. The Yale University Open Data Access project is set to change this. They have developed a model to facilitate access to patient-level clinical research data to promote wider availability of clinical trial data and independent analysis by external investigators.

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 recombinant bone morphogenetic protein-2 (rhBMP-2) product.