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The Yale Open Data Access Project: How Johnson & Johnson Is Leading the Way on Clinical Data Transparency

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Advancing the science that can improve the lives of people around the world is core to our mission at Johnson & Johnson. One of the many ways we believe we can do this is by sharing our data from clinical trials with external researchers, which is why, in 2014, we began partnering with the Yale Open Data Access (YODA) Project on a pioneering data-sharing model.

Under the agreement, YODA (led out of the Yale School of Medicine) serves as an independent body to review requests from investigators and physicians seeking access to our clinical trials data, and makes final decisions on data sharing.

Our partnership represented the first time any company had collaborated with a completely independent third party to review and make decisions regarding all requests for clinical data.

Today, I am pleased to report that The New England Journal of Medicine has published a perspectives article, “The Yale Open Data Access (YODA) Project—A Mechanism for Data Sharing,” that I had the honor of co-authoring with Harlan M. Krumholz, M.D., SM, leader of the YODA Project and Director of the Center for Outcomes Research and Evaluation.

In the article, Dr. Krumholz and I elaborate on the fact that Johnson & Johnson has delivered on our commitment to sharing our pharmaceutical data, followed by our medical device data, through the YODA project.

Within the first year, we received 29 requests for data, and all were subsequently approved. Our Johnson & Johnson companies also prepared 123 trials for use as resources by researchers worldwide. We are aware of two papers in development from data we’ve shared through the YODA project, and look forward to seeing more in the future.

How Changing Data Policies Can Advance Science, Medicine and Public Health

We believe that granting an independent academic group ultimate authority regarding the release of clinical trial data provides a fair and unbiased approach.

We do this based on commonly agreed-upon principles, including protecting privacy and honoring the commitments we’ve made to clinical trial participants, approving only scientifically-sound proposals, ensuring that access is governed by data use agreements, requiring researchers to report the results of their work, and providing transparency in our decision-making.

The research community has made great progress in data sharing, but we are still at the beginning of this transformation. As Dr. Krumholz and I state in our article: “The ultimate measure of our success will be whether this approach creates a culture of openness on par with those of other scientific disciplines, increases the volume of high-quality medical science—and helps a researcher with a great idea change clinical practice.”

As our environment continues to evolve, we are encouraged by the fact that more and more stakeholders are adopting policies to allow for greater access to clinical trial data. A number of approaches are being pursued by others, in addition to our own efforts, and data from these programs will help determine how best to collectively share data.

We believe that collaboration among all stakeholders—industry, academia, patient groups and governments—is essential to developing a solution that truly advances science, medicine and ultimately public health.

Together, we can further our understanding of diseases, expand the knowledge base needed to develop new treatments, and ultimately generate new insights and more complete evidence that will enable better healthcare decisions for patients.

Joanne Waldstreicher, M.D., is Chief Medical Officer for Johnson & Johnson. In this role, she has oversight across pharmaceuticals, devices and consumer products for safety, epidemiology and clinical and regulatory operations. She also has responsibility for the development of corporate ethical science, technology and research and development policies, including those related to clinical trial transparency and compassionate access.

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