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 has 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.The YODA Project model provides a means for rigorous and objective evaluation of clinical trial data to ensure that patients and physicians possess all necessary information about a drug or device when making treatment decisions. This process includes both coordinating independent examinations of all relevant product data by two separate qualified research groups and making all patient-level clinical research data available for analysis by other external investigators. The model is designed to provide industry with confidence that the analyses will be scientifically rigorous, objective and fair.
Of note, several features of the model are specifically focused on promoting transparency and protecting against industry influence:
- Any company engaging in the model must provide all relevant product data
- Two independent research groups, selected after a competitive application process, systematically review and analyze all relevant product data
- An independent Steering Committee, including leaders in the field of clinical research and biomedical ethics, advise the YODA project team
- A Clinical Advisory Committee, including leaders in the clinical practice that uses the product under evaluation, advise the project
- Project leadership are committed to transparency, publication, and making the data publicly available
Objectives of the YODA Project
The YODA Project is rooted in the view that patients, providers, and industry will be better informed when academic investigators are able to facilitate the independent assessment and dissemination of data relevant to the benefits and harms of industry products. These assessments will allow physicians and patients to base their decisions on the most comprehensive and contemporary evidence available.
Traditionally, patient-level data that can be used to assess medical treatments have not been made available to researchers outside of industry. As a result, independent researchers who are interested in evaluating a product have relied on data summaries and published manuscripts, which often provide an incomplete picture because much of the data is not published. The project’s goal is to promote clinical trial program data access more widely, increasing transparency, protecting against industry influence, and accelerating the generation of new knowledge.
Medtronic Research Grant to Yale University Establishes New Model for Independent Analysis and Dissemination of Industry Data
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. 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.
- YODA Project General Steering Committee Members
- YODA Project Clinical Steering Committee Members
- Systematic Review Team at Oregon Health and Science University
- Systematic Review Team at University of York
- YODA 2012 Conference Participants
- YODA Project Consultants
- Yale Office of General Council
- Yale Office of Grant and Contract Administration