A Decade Of Data Sharing: Insights From J&J And Yale's YODA Project
A conversation with Joseph S. Ross, MD, MHS, and Karla Childers, MS
Sharing clinical trial data is critical to advancing science, medicine, and public health. Every year, vast amounts of participant-level data are generated. However, when unpublished or unshared, the potential for those data to inform clinical practice is lost, limiting the valuable contributions of research participants. To unlock the full impact of clinical trial data, sharing that data is essential to drive innovation and accelerate meaningful discoveries.
Over the past decade, the rise in data sharing has underscored the importance of openness within the industry. Since 2014, Johnson & Johnson has partnered with the Yale University Open Data Access (YODA) Project to create a consistent framework for independently assessing external research proposals that request access to Johnson & Johnson and other companies’ clinical trial data. This partnership has strengthened transparency, expanded scientific knowledge, uncovered new insights, and spurred innovation.
In this Q&A, Joseph S. Ross, MD, MHS, Professor of Medicine (General Medicine) and of Public Health (Health Policy and Management) at Yale University and a member of the Center for Outcomes Research and Evaluation (CORE) at Yale-New Haven Hospital, and Karla Childers, MS, head of bioethics-based science and technology policy at Johnson & Johnson, reflect on a decade of data sharing and the lasting impact of the YODA Project on the field.
Why is sharing clinical trial data important, and how does the YODA Project contribute to this effort?
Childers: Sharing clinical trial data is essential for advancing our understanding of diseases, expanding the knowledge needed to develop new treatments, and uncovering insights that lead to more informed healthcare decisions. By responsibly sharing clinical trial data, we aim to establish better healthcare data-sharing practices that help enable the generation of new insights and informed decision-making that ultimately improve patient care.
Yale University and Johnson & Johnson established the YODA Project with that goal in mind. As of January 1, 2025, the YODA Project has received, reviewed, and approved 431 complete research proposals, resulting in 157 publications in prominent medical journals such as JAMA Neurology, World Psychiatry, Lancet Psychiatry, and the American Journal of Respiratory and Critical Care Medicine.
How has clinical trial data sharing evolved over the past decade?
Childers: Over the past decade, collaboration among sponsors, academia, patient groups, and governments has helped develop solutions that propel science, medicine, and public health forward. This collective effort has helped establish policies and programs that make valuable research data accessible to the broader scientific community, fostering innovation and discovery.
As an example, in 2015, the NIH reinforced the importance of data accessibility by announcing its intention to make digital data from its funded studies publicly available. The launch of the Data Management and Sharing (DMS) Policy in January 2023 further reinforced this commitment. Under this policy, researchers receiving NIH support must share data from their studies. New proposals and competitive grant renewals must include a DMS outlining the expected data, associated metadata, timelines for preservation and access, distribution and reuse factors, oversight arrangements, and budget for allowable costs. After years of stakeholder engagement, this policy reflects a unified effort to maximize the public’s investment in research and promote transparency.
The pharmaceutical industry also has embraced data sharing, with sponsors partnering with multi-sponsor data-sharing platforms like Vivli to make their data accessible. Regulatory agencies, such as the European Medicines Agency and Health Canada, have introduced more progressive data-sharing requirements for companies seeking drug approvals. Additionally, organizations like the World Health Organization and the National Academy of Medicine have published positions emphasizing the need for responsible data sharing. For example, the Gates Foundation requires that data underlying published research be made immediately available and openly accessible.
What challenges has the YODA Project encountered over the years? What changes were made as a result?
Ross: Early on, one of the main issues was the limited number of “seats” available on the secure data-sharing platform and the restricted storage space for analyses, unless additional capacity was secured. By changing the underlying data-sharing platform, we can now accommodate all researchers, which is a significant improvement. Despite this progress, there has been a growing demand for specific software, additional storage space, and access to different types of data, highlighting the need for ongoing platform enhancements.
Another challenge in the project’s early days was the lack of prioritization by some investigators who requested data access. Many researchers treated the data as an "extra" project, often failing to complete the analysis. To address this issue, the YODA Project clarified its expectations, emphasizing the requirement that researchers report the results of their analysis. Additionally, the project implemented an annual review process to assess whether investigators were actively working on their projects and still needed access to the data platform.
These changes have allowed the YODA Project to manage its resources more effectively and ensure the efficient use of the data-sharing platform.
What best practices should industry experts know when evaluating research proposals?
Ross: When evaluating research proposals, industry experts should adhere to several best practices to ensure research integrity and effectiveness. One critical practice is pre-specification, which involves asking investigators to clearly outline their research plans in advance. This ensures that the investigators have thoughtfully designed their studies, that the data are suitable for the intended purpose (i.e., the necessary variables are available), and that peer reviewers can verify adherence to the proposed plan when results are published.
For example, the YODA Project evaluates all requests from researchers seeking access to anonymized clinical trial data from Johnson & Johnson. The YODA Project operates on key tenets, including:
- Protecting patient privacy and honoring the commitments made to clinical trial participants
- Approving only scientifically sound proposals
- Governing access through data use agreements
- Requiring researchers to report their findings
- Providing transparency in decision-making
These principles uphold the integrity of the research process and promote the responsible and effective use of data.
By adhering to these best practices, industry experts can foster high-quality research that advances science and medicine while maintaining ethical standards and protecting the interests of all stakeholders involved.
What do you believe is the future of clinical data sharing?
Ross and Childers: The future of clinical data sharing will likely be shaped by emerging technologies such as AI and ML. These tools are expected to revolutionize the efficiency and reliability of data-sharing processes. For instance, AI and ML can automate and streamline data management processes, reducing the time and effort required for data cleaning and analysis, which enables more efficient and accurate sharing of clinical data. Additionally, AI-driven security measures can enhance the protection of sensitive clinical trial data, ensuring that it is shared securely and complies with regulatory requirements.
As the volume of available data increases, AI and ML offer a tremendous opportunity to extract insights, particularly from underutilized data types such as imaging data or videos from procedures. These advanced technologies can uncover patterns and relationships that were previously inaccessible, thereby accelerating medical research and innovation.
Furthermore, opportunities will likely emerge to link clinical trial data with other data sources. This integration could provide additional insights around prognosis and diagnosis, particularly when data from multiple trials are aggregated. This holistic approach would enable researchers to gain a more comprehensive understanding of diseases and treatments, ultimately improving patient care and advancing medical science.
About The Experts:
Joseph S. Ross, MD, MHS, is a Professor of Medicine (General Medicine) and of Public Health (Health Policy and Management), a member of the Center for Outcomes Research and Evaluation (CORE) at the Yale-New Haven Hospital, and an Co-Director of the National Clinician Scholars program (NCSP) at Yale.
Dr. Ross’s research focuses on examining factors which affect the use or delivery of recommended ambulatory care services for older adults and other vulnerable populations. He also collaborates with a multi-disciplinary team of investigators under contract for the Centers for Medicare and Medicaid Services to develop statistical models that are used to measure and publicly report hospital and ambulatory care clinical outcomes using administrative data.
Dr. Ross co-directs the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI), the YODA Project, the Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT) at Yale Law School, and leads efforts at Yale-New Haven Health System in collaboration with the National Evaluation System for health Technology.
Karla Childers, MS joined Johnson & Johnson (J&J) in October 2013 in the Office of the Chief Medical Officer where her primary responsibility has been leading and coordinating various ethics-based, science and technology policy projects.
Her longest running responsibility has been the support and coordination of Johnson & Johnson’s Clinical Trial Data Transparency Initiative, including the management of the YODA Project data sharing collaboration. Karla is the chair of the J&J Bioethics Committee, which serves as an internal forum providing advice on bioethical questions within J&J.
She is responsible for the management and conduct of that committee and relevant bioethics consultations. She serves as a bioethics subject matter expert for various internal and external science and technology policy work and coordinates the internal bioethics educational program sponsored by the Office of the Chief Medical Officer.
Karla received her Bachelor of Arts in chemistry from Indiana University-Purdue University in Indianapolis and a Master of Science in jurisprudence from Seton Hall Law School. She is also a graduate of Columbia University with a Master of Science in bioethics.