YODA Project: 'Opening Up' Clinical Trials & Research Practices

Many patients and their physicians often make treatment decisions with access to only a fraction of the relevant clinical research data because details about many clinical studies or clinical trials are never made available in published biomedical literature. The YODA Project may change this.

YODA Project Model

The Yale University Open Data Access (YODA) Project has developed a new model to facilitate access and wider availability to patient-level clinical research and/or clinical trial data for further independent analysis by external investigators.

Traditionally, independent researchers who were interested in evaluating a product had to rely on data summaries and published manuscripts, which often provide an incomplete picture because much of the data is not published.

Using the new model, the YODA Project provides a means for more 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 new 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 process was also designed to provide industry with confidence that the analyses will be scientifically rigorous, objective and fair. 

For more information about the key features of the model, go to the YODA Project Home Page.

Medtronic Uses the YODA Project Model

After a two-years-long process, the Yale University Open Data Access (YODA) project completed its first initiative with the publication of two independent reviews of Medtronic data on recombinant human bone morphogenetic protein-2 (rhBMP-2) in the "Annals of Internal Medicine". See Annals of Internal Medicine tip sheet for June 18, 2013.

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, they disseminated all Medtronic clinical research data on rhBMP-2 to external investigators.

Medtronic was the first drug or medical device company to contract with YODA to allow access to all of its clinical trial data for independent reanalysis. Medtronic agreed to complete data transparency, allowing two independent research groups to reanalyze all the data that had been collected.

According to the YODA project team,  they hope that this project marks a major step toward a cultural shift in thinking about data sharing. According to them, publication of the rhBMP-2 reviews in the Annals of Internal Medicine is "an historic moment in the emerging era of open science."

Richard E. Kuntz, MD, MSc, Chief Scientific, Clinical & Regulatory Officer at Medtronic, Inc., claims, "all stakeholders should benefit from a transparent process that produces reliable information about the benefits and harms of the products being studied."

Ultimately, embracing the concepts of  'open access', 'open data', and 'open discussions' and exchange of information should lead to a more accurate and trustworthy assessment of the benefits and harms of medical products – a 'win-win-win' for industry, physicians, and patients. The FDA may want to pay close attention to the YODA Project.