In January 2014, the Yale Open Data Access (YODA) Project began a collaboration with Johnson & Johnson to establish an independent process promoting data sharing. Since then the YODA Project has fielded more than a dozen requests for clinical data from researchers and played a key role in pushing the clinical research field toward a more open way of operating.
Part of Yale’s Center for Outcomes Research and Evaluation (CORE), the YODA Project began in 2012 with the mission of promoting scientific inquiry and lowering barriers to data access. The partnership with Johnson & Johnson gives the YODA Project all decision-making authority over the release of the company’s pharmaceutical trial data.
The idea is to make these data available to researchers who can put it to good use. But there is also a larger aim, says Joseph S. Ross, M.D., M.H.S., co-director of the YODA Project: “We’re trying to create a paradigm shift in the way clinical research is done,” Ross says. “It’s about honoring the commitment the patients have made to research, [and] about making sure all of the evidence that could potentially inform a decision about whether a patient should use or a physician should prescribe a given therapy is available.”
Investigators requesting data must submit a research proposal to the YODA Project. The application and review process is key to the idea of promoting responsible research, says Ross, also associate professor of medicine and assistant professor of public health.
Studies have found that up to half of all clinical data are never published—data that could move medicine forward. The YODA Project aims to shift this paradigm, and to take decision-making power about data sharing “out of the hands of these large companies that had a major investment in what happens with the data,” Ross says.
In January of this year, on the same day that Johnson & Johnson announced it expanded its collaboration with the YODA Project to include data from clinical trials of medical devices, a committee of the Institute of Medicine (IOM) called on stakeholders in the medical research process to “foster a culture where data sharing is the expected norm.” The committee recommended that all stakeholders in clinical trials commit to “responsible strategies aimed at maximizing the benefits, minimizing the risks, and overcoming the challenges of sharing clinical trial data for all parties.” The IOM also recommended the data be made available within 30 days of a product’s approval or 18 months after a study’s completion.
“I think it’s fair to say that YODA has played an important role in moving this issue forward, together with several other organizations,” says Bernard Lo, M.D., professor emeritus of medicine at the University of California, San Francisco and the committee’s chair. “Sharing clinical trial data strengthens the science that is the basis for good clinical care.”
Johnson & Johnson chose to collaborate with the YODA Project “because we wanted a partner with a prominent track record that is known for its leadership in data sharing and that would be able to work with us across every sector of our business,” says Joanne Waldstreicher, M.D., Johnson & Johnson’s chief medical officer. “Sharing clinical trials data with the wider research community will speed up new medical discoveries and accelerate improvements in public health. Over the next five years, I would expect a more open and collaborative environment across industry, academia, patient groups, and foundations, where data sharing becomes the norm and science accelerates at an even faster pace, all of which is very exciting.”
In a Fortune magazine ranking of the world’s most admired companies in 2015, Johnson & Johnson jumped eight spots to number 11, ranking first in the pharmaceutical category. The article cited a reason for the improvement: “Last year [Johnson & Johnson] became the first large medical device maker to agree to share clinical trial data and diagnostic tests with researchers at Yale University.”
A decade ago Ross and Harlan M. Krumholz, M.D., S.M., the Harold H. Hines Jr. Professor of Medicine and principal investigator of the YODA Project, “were kind of like gadflies [urging open science]. Now, the IOM has recommended it, [and] journals are recommending it,” Ross says.
Ross envisions a day when data sharing is so commonplace that “when a trial is done, the data [are] deposited, and the processes are in place for making it available on one website,” he said. “What I really hope is that we’re out of business.”