At the conclusion of the analysis period (anticipated Q1 2017), participants who have completed analyses will be invited to attend a meeting to present and discuss results. Groups with similar strategies or research topics will be encouraged to integrate efforts in a combined or companion manuscript(s). All results will undergo peer review with the goal of publication in an open-access journal. Finally, the pilot will be evaluated with the goal of replicating it for other neuropsychiatric disorders.
The YODA Project: Yale Open Data Access
The YODA Project has been at the forefront of the clinical trial data–sharing movement since its inception in 2011, advocating for the responsible sharing of clinical research data, open science, and research transparency, while serving as an independent intermediary between data generators and data users to facilitate access to data. The Project is committed to supporting research focused on improving the health of patients and informing science and public health while protecting the rights of research participants.
Through partnerships with Johnson & Johnson and Medtronic, Inc, the YODA Project worked to establish standards to guide its efforts through experience and input from the public and stakeholders. The project iteratively developed a model to make shared data available to other investigators, including de-identified participant-level clinical research data and/or comprehensive reports of clinical research, such as full clinical study reports. This level of detail is not customarily found in journal publications.
The YODA Project aims to support and promote scientific research using shared clinical trial data that may advance science or lead to improvements in health as well as health care delivery. The project is guided by the following core principles, which reflect the overall mission of the project to promote open science:
• Promoting the sharing of clinical research data to advance science and improve public health and health care
• Promoting the responsible conduct of research
• Ensuring good stewardship of clinical research data
• Protecting the rights of research participants
In 2014, the YODA Project entered into an agreement with Johnson & Johnson to develop a policy to share clinical data for all trials of the company’s pharmaceutical products; data became available to external investigators through this initiative in October 2014. The scope of this agreement was expanded in 2015 to include trials of medical device products approved in 2014 and onwards. Clinical trial data are currently available for many medical conditions, including schizophrenia, bipolar disorder, and ADHD, as well as non-psychiatric conditions such as diabetes mellitus and rheumatoid arthritis. Johnson & Johnson schizophrenia clinical trial data are available independently of the OPTICS Project, as well as through the OPTICS Project.
Within the current YODA Project model, investigators can request access to available clinical trial data by submitting a research proposal that describes their aims, methods, and statistical analysis plan, among other information. There is no charge to access the data. The YODA Project evaluates each submitted request to ensure it has scientific merit and on this basis makes the decision to provide access to the requested data, which are made available via a secure data-sharing platform. Once investigators have access to the data, the expectation is that they will pursue their proposed research and publish their results in the peer-reviewed literature or report their findings on the YODA Project website, which ensures that their work informs the larger scientific community.
The NIMH perspective
NIMH has a long-standing history in promoting data sharing for accelerating mental health research through initiatives and polices and is a strong proponent of endeavors such as the OPTICS Project.6 One of the transformative data-sharing initiatives led by NIMH was the NIMH Human Genetics Initiative, driven by the principle that making data and biospecimens rapidly available to the broader scientific community is essential to maximize scientific progress.
Dr Ross is Associate Professor in the Section of General Internal Medicine and the Robert Wood Johnson Foundation Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine; Associate Professor in the department of health policy and management, Yale University School of Public Health; and Co-Director of the YODA Project at the Center for Outcomes Research and Evaluation, Yale-New Haven Hospital in Connecticut; Dr Addington and Dr Senthil are Health Scientist Administrators at the Genomics Research Branch, National Institute of Mental Health in Bethesda, MD; Dr Lehner is Director of the Office of Genomics Research Coordination, National Institute of Mental Health in Bethesda, MD; and Dr Wilcox is a Scientific Director and Fellow at Janssen Research & Development, LLC in Titusville, NJ.
The preparation of this article was not supported by any external grants or funds. The authors assume full responsibility for the accuracy and completeness of the ideas presented. Dr Ross receives support through Yale University from Medtronic, Inc and Johnson & Johnson to develop methods of clinical trial data sharing, from the Centers of Medicare and Medicaid Services to develop and maintain performance measures that are used for public reporting, and from the FDA to develop methods for post-market surveillance of medical devices. Dr Wilcox is employed by Janssen Research & Development, LLC.
1. Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press; 2015.
2. European Federation of Pharmaceutical Industries and Associations. The Power of One: A Commitment to Collaboration; 2013. http://www.efpia.eu/uploads/documents/EFPIA-AR-2014.pdf. Accessed December 2, 2015.
3. European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America. Principles for Responsible Clinical Trial Data Sharing; 2014. http://phrma.org/sites/default/files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataSharing.pdf. Accessed December 2, 2015.
4. Trans-NIH BioMedical Informatics Coordinating Committee. NIH Data Sharing Policies; 2013. https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_policies.html. Accessed December 2, 2015.
5. National Institute of Mental Health. Data Sharing Expectations for Clinical Research Funded by NIMH; 2015. http://grants.nih.gov/grants/guide/notice-files/NOT-MH-15-012.html. Accessed December 2, 2015.
6. Lehner T, Senthil G, Addington AM. Convergence of advances in genomics, team science, and repositories as drivers of progress in psychiatric genomics. Biol Psychiatry. 2015;77:6-14.