Yale University Open Data Access (YODA) Project
Broad Advantages to Data Sharing as Outlined by the IOM
- Reinforcement of open scientific inquiry
- Verification, refutation, or refinement of original results
- Promotion of new research through existing data
- Encouragement of the appropriate use of empirical data in policy formulation and evaluation
- Improvement of methods for data collection and measurement
- Encouragement of multiple perspectives
- Provision of resources for training in research
- Protection against faulty data
- Greater application of scientific research in decision-making
- Reduction of the expense of duplicative data collection and the concomitant burden on human subjects
- Respect for the desire of respondents to contribute to societal knowledge
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. has provided a grant to Yale University to apply the YODA Project model in practice for the first time. Yale will lead 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 will be conducted independently by two academic teams with full access to all Medtronic’s clinical trial, post-marketing and safety data about rhBMP-2. The results of the reviews are anticipated to be released June 2013.
In addition, the grant supports the dissemination of all Medtronic clinical research data on rhBMP-2 to external investigators, which is also expected for June 2013.