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Office of the Chief Medical Officer

Advancing Clinical Trial Data Sharing Through the Yale University Open Data Access Project

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Sharing of clinical trial data is critical to the advancement of the science that is the foundation of medicine and public health. It furthers our understanding of diseases, expands the base of knowledge needed to develop new treatments and generates new insights and more complete evidence to enable better healthcare decisions for patients.

We honor the patients who volunteer their time and their bodies to participate in clinical trials by ensuring their data are shared responsibly to inform decisions that will help the greatest number of people.

As such, we partner with the Yale University Open Data Access (YODA) Project––a pioneering data-sharing model. Through the YODA Project, we enable a fair and unbiased approach for assessing external research proposals requiring the use of clinical trial data from our Pharmaceutical, Medical Device or Consumer Health sectors. We grant the YODA Project full decision rights regarding the release of our clinical trial data.

Discussing Clinical Data Sharing with Joanne Waldstreicher, M.D.
Discussing Clinical Data Sharing with Joanne Waldstreicher, M.D.

Our engagement with the YODA Project, which began in 2014, marked the first time a company had collaborated with an independent academic group to objectively make decisions on proposals for access to clinical data from our research in pharmaceuticals. Medical devices followed in 2015 and consumer healthcare products in 2017. Researchers can request data here: http://yoda.yale.edu/how-request-data.

The YODA Project enables researchers to access deidentified participant-level trial data and research reports, which provide extensive details about the methods and results of a clinical trial. The YODA Project serves as an independent review panel to make decisions about requests from researchers. Applicants submit proposals directly to the YODA Project. The YODA Project scientists conduct a thorough review of the scientific merit of the proposal and make the decision whether we will provide access to these data.

Five-year data on the YODA Project were published in Nature’s open access journal, Scientific Data, in 2018. The research findings both defined best practices for sharing clinical trial data and outlined outstanding challenges to further refine how data are shared.

By responsibly sharing clinical trial data, we aim to pave the way for better healthcare data sharing practices to improve health outcomes for the greatest number of people.

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