The Annals of Internal Medicine heralds a historic moment in the emerging era of open science as it features 2 systematic reviews on rhBMP-2 that are based on patient-level data from all clinical trials conducted by Medtronic, which were shared through the Yale University Open Data Access (YODA) Project.
Tag Archive for: clinical trials
A NY Times article discusses the issues with opening up clinical trials data. More researchers are insisting on seeing all the data behind all clinical trials for drugs, not just the rosy reports that companies choose to release.
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.
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