The Yale Open Data Access (YODA) Project, a pioneering initiative to promote open science and facilitate sharing of clinical trial research data, has reached the milestone of supporting more than 100 publications.
These research studies, which stretch across many medical fields, were only possible because of data shared through the YODA Project platform. Over the past decade, many research funders have started sharing data, including large pharmaceutical companies and the National Institutes of Health (NIH), and these open science-enabled manuscripts demonstrate the value of this new era of clinical science.
The YODA Project was launched in 2013 by Joseph S. Ross, MD, MHS, professor of medicine (general medicine), Yale School of Medicine, and of public health (health policy and management), Yale School of Public Health, and Harlan M. Krumholz, MD, Harold H. Hines, Jr. Professor of Medicine (Cardiology), Yale School of Medicine, professor of public health (health policy), Yale School of Public Health, and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation (CORE).
Ross and Krumholz have been pursuing ways to improve the clinical research ecosystem and accelerate progress. They discovered that a disturbing number of clinical trials were not reported or published, and that clinical trial data were commonly inaccessible to other researchers, hindering the ability to leverage the contributions of the participants and the original research group. They built the YODA Project to demonstrate that clinical trial data could be shared responsibly, and effectively – and could foster an open science culture in clinical research.
We hope that we can be part of those [data sharing] conversations as investigators figure out how to do it and do it in a way that makes data as easily accessible without it being a burden, while still protecting patient confidentiality and ensuring that the investigators that are going to use the data are good stewards of it.
Joseph S. Ross, MD, MHS
“In the time since we started this and started talking about it, writing about it, and giving talks, there's been a lot of change moving the entire field towards data sharing,” said Ross. “We hope that we can be part of those conversations as investigators figure out how to do it and do it in a way that makes data as easily accessible without it being a burden, while still protecting patient confidentiality and ensuring that the investigators that are going to use the data are good stewards of it.”
“It’s been exciting to first see the originally submitted data requests from researchers who have these novel and innovative ideas and then to receive notification that they were actually able to successfully use the data and disseminate their results to the broader research community,” noted Jessica Ritchie, MPH, senior project manager for the YODA Project.
It’s been exciting to first see the originally submitted data requests from researchers who have these novel and innovative ideas and then to receive notification that they were actually able to successfully use the data and disseminate their results to the broader research community.
Jessica Ritchie, MPH
The project has enjoyed a highly successful partnership with Johnson &Johnson, including the Janssen Pharmaceutical Companies of Johnson & Johnson. The platform is currently making data available for more than 400 of the company’s clinical trials.
When the World Health Organization (WHO) was doing an evidence review and putting out its report on the management of tuberculosis, one of the main pieces of evidence cited was the meta-analysis conducted using shared data through the YODA Project. “That’s a big deal when information goes into a seminal professional guideline like that,” says Ross.
“The YODA Project has changed minds about what is possible in research,” said Krumholz. “In the beginning, researchers felt that they owned data and considered it a competitive advantage over other researchers. There were many naysayers. Increasingly, we are seeing researchers who share data avidly and work together to make progress against disease. The platform has provided important infrastructure to facilitate data sharing and collaboration.”
Increasingly, we are seeing researchers who share data avidly and work together to make progress against disease. The platform has provided important infrastructure to facilitate data sharing and collaboration.
Harlan M. Krumholz, MD
Now more large companies are using the platform. In addition, the National Institutes of Health (NIH) just enacted a strengthened data sharing policy that's going to require all NIH-funded investigators to share the data generated through funded research. The YODA Project played a key role in that evolution of thinking about research data.
“We are proud that Yale and CORE could play such a pivotal role in advancing the way we do research,” said Krumholz. The pair, Ross and Krumholz, subsequently co-founded medRxiv, the leading preprint server for clinical science. Together they are continuing their efforts to promote collaborative science, and to accelerate science for the good of society.
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