YODA Project

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. The following principles reflect the overall mission of the project:

  • Promote open science
  • Promote transparency
  • Ensure good stewardship of clinical trial data
  • Serve the needs of society
  • Respect the legitimate concerns of the industry


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 YODA Project model aims to make all patient-level clinical research data available for analysis by other external investigators.

Acknowledgments

The YODA Project would like to acknowledge many individuals for their contributions to this endeavor:

  • 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

Leadership & Contact Information

Steering Committees

Press & Publications

Conferences

Data Sharing Projects