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 participant-level clinical research data to promote wider availability of clinical trial data and independent analysis by external investigators. These assessments will allow physicians and patients to base their decisions on the most comprehensive and contemporary evidence available.
The YODA Project 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 making participant-level clinical research data available for analysis by external investigators. The project is designed to provide partners with confidence that the analyses will be scientifically rigorous, objective, and fair. The YODA Project is guided by the following core principles, which reflect the overall mission of the project to promote open science by:
- Promoting the sharing of clinical research data to advance science and improve public health and healthcare
- Promoting the responsible conduct of research
- Ensuring good stewardship of clinical research data
- Protecting the rights of research participants
What the YODA Project Does
The YODA Project is an effort by a group of academically-based clinical researchers to facilitate access to participant-level clinical research data and/or comprehensive reports of clinical research, such as full Clinical Study Reports [CSRs], with the aim of promoting scientific research that may advance science or lead to improvements in individual and public health and healthcare delivery. The YODA Project has served as a trusted third party in a variety of collaborative efforts to make scientific data more broadly available to researchers for the betterment of patients, scientific research, and society. Ongoing projects include conducting independent reviews of requests for access to pharmaceutical and medical device company data that could enable new scientific discoveries. As the expectation for open science and research transparency expands, the YODA Project continues to evolve as a leader in responsible data access while maintaining the touchstone of its core values.
What the YODA Project Does Not Do
The YODA Project has not generated nor owns the data being made available through these open science projects. This impartial perspective enables the YODA Project to promote its principles in a manner uninfluenced by individual stakeholder biases and to work as a mediator, facilitator, and activist for responsible data sharing.
- 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