By Maxine Bookbinder

March 15, 2017 | In 2014, Johnson & Johnson opened its medical and consumer businesses to researchers worldwide, thanks to an initiative with the Yale Medical School of Medicine. In January, the company announced that it would share results from trials of the consumer businesses of Johnson & Johnson.

The Yale University Open Data Access (YODA) Project, comprising academic clinical researchers, gives global access to clinical research data to promote and encourage scientific research for the purpose of increasing discoveries and advancing public health and healthcare delivery. Johnson & Johnson has previously shared pharmaceutical and medical device data through YODA.

Joseph Ross, Associate Professor of Medicine and Public Health at Yale and Harlan Krumholz, YODA Project co-directors and co-founders, have long advocated for increased data sharing and transparency, open science, and improved access to encourage more research and inventiveness.

“Our purpose is setting the standards within the field. We try to put everything on our website, including requests, responses, and data publication,” says Ross. “J&J transfers full authority to us; we stand as an independent group between the external investigators who want to use the data and J&J, who generated the data. J&J has gone farther than any other company and said, if you want to use our data, go ask Yale.”

The partnership is one way Johnson & Johnson and the YODA Project promote scientific discovery and data transparency. J&J makes available clinical trial data from across all of R&D, including pharmaceutical, consumer, and medical device businesses. Requests are submitted to the YODA Project, an independent intermediary.

“We are the first company to do an agreement with an external third party company and give them full decision rights on access,” says Joanne Waldstreicher, Johnson & Johnson Chief Medical Officer. “Since we’ve done that, several other companies now partner with academic colleagues.”

Researchers, investigators, and physicians seeking access to clinical trial data must submit a proposal to the YODA Project for specific data and outline what their research project is measuring and the desired outcome goals. Proposals, which are reviewed blindly, are read within two weeks, but final approval and access may take up to three months, depending upon the applying institution’s review time of the data use agreement. All information about the requests, including the proposals, responses, and results, is posted on the YODA Project’s website (http://yoda.yale.edu/). According to legal agreements, data are available for analysis on a secure statistical platform, SAS, and users cannot download information, share with third parties, or use the data for commercial purposes.

The YODA Project asks that all resulting research be published for greater scientific understanding and “the wider scientific community,” says Ross. If it is not published, the Project requires investigators to post a summary of the results on its website. 

Confidentiality safeguards protect participant privacy. J&J anonymizes data and researchers must sign a confidentiality agreement pledging not to re-identify study participants.

“At J&J, we believe that sharing clinical trial data advances the science that is the foundation of medical care,” says Waldstreicher. “That’s why we were looking for a clinical data sharing mechanism in a responsible way. We wanted a more consistent and objective way to share data. It is completely objective. That was the philosophy behind the YODA Project.”

Waldstreicher says the project allows J&J to share on a much wider spectrum rather than on an individual trial basis. “Researchers can discuss with YODA to decide if particular data will help advance their own research,” she explains. “This is on a much larger scale than we could have ever done in the past.”

The YODA Project’s initial shared data collaboration was for one product with the medical device company Medtronic, Inc. Soon afterward, Krumholz ran into his former fellow Harvard Medical School classmate Waldstreicher at a conference, where they discussed their common passion for data sharing. About one year later, the YODA Project – J&J collaboration launched.

Ross says the project addresses the challenge of research efficiency—and inefficiency—and replication. “If large sponsors such as J&J make data available to smaller investigators, it maximizes the value of the data and its scholarship by allowing it to be used by more researchers rather than just one and opens it to a broader field.”

This transparency increases patients’ confidence in a trial, Ross adds. “If a company is going to make its data available to other researchers to use, it’s saying, ‘We are willing to be held to a higher standard and are not afraid of transparency and want to promote open science.’”

Since 2014, more than 180 trials have been anonymized and prepared for data-sharing; at least two research groups generated new research and published papers using shared J&J data. Out of the approximately 60 access requests received by the YODA Project, only a handful could not be approved, either because the requested data were not available or the proposals were not sufficiently clear. 

The next step, says Ross, is to figure out how other groups, from smaller ones without the resources of a Johnson & Johnson to behemoths such as the NIH, can share data. The YODA Project team is talking with other companies and currently working with a small medical device company, SI-BONE. While similar collaborations, such as Duke University’s SOAR Initiative with Bristol-Myers exist, Ross maintains that the YODA Project – J&J partnership is unique.

However, despite the benefits of scientific innovation and advancement, data sharing remains controversial due to what some critics deem an uneven cost-benefit analysis. “Some researchers still question whether the scientific return is worth the cost, and whether money is better spent on other studies. It’s a healthy discussion,” says Waldstreicher. “At J&J, we not only believe that sharing clinical trial data advances science and medicine but is honoring the patients and participants in our clinical trials. It renews our credo that puts mothers and fathers and children ahead of everything.”