Johnson & Johnson has announced that Janssen Research & Development, and a group of leading research organizations are launching the OPTICS Project -- Open Translational Science in Schizophrenia.
The project will create a new forum for collaborative analysis of Janssen's clinical trial data with data available from the National Institutes of Health (NIH) about schizophrenia. Its goal is to advance scientific knowledge about the disease and create new models for conducting research. The current collaborators and members of the project's advisory board are Yale University School of Medicine, Rutgers University, Harvard T.H. Chan School of Public Health, and the National Institute of Mental Health (NIMH).
"Sharing clinical trial data advances the science that is the foundation of medical care," said Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson. "Over the past year, Johnson & Johnson has worked with the Yale School of Medicine Open Data Access (YODA) Project to provide participant-level data from our pharmaceutical and medical device clinical trials to more than a dozen qualified researchers."
The OPTICS project will foster collaboration among qualified researchers in the analyses of Janssen's clinical trial data about schizophrenia therapies made available by Johnson & Johnson through the YODA project (http://yoda.yale.edu/optics-trial-bundle) with data about schizophrenia available through the National Institutes of Health's Center for Biotechnology Information (http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/collection.cgi?study_id=phs000887.v1.p1). This collection includes studies about the molecular etiologies of schizophrenia in a variety of populations. This is the first time data about the causes of the disorder and data from clinical trials of therapies will be available to researchers in one place.
"As a society, we have a responsibility to further advance care for people with mental illnesses," said Husseini K. Manji, MD, Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC. "Schizophrenia can be a devastating illness and has a significant impact on individuals living with the disease, as well as their families. OPTICS will foster open-science collaborations and lead to new, fundamental insights about schizophrenia so that we can improve therapies and treatments, and ultimately find a cure."
Marsha A. Wilcox, EdD, ScD, Scientific Director and Fellow, Janssen Research & Development, LLC, is leading the project. All data analyses proposed for OPTICS must support at least one of three defined project goals:
• Advance efficacy and safety of medicines for schizophrenia;
• Increase understanding of schizophrenia, including disease natural history, subtypes, and causes; and
• Contribute to the development of analytic and design methods for disparate data types, including novel statistical methods and research designs.
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Qualified investigators may apply to participate in the collaboration. They need to agree to meet the data access and use requirements of all data owners. They also must agree that any knowledge generated from this project (e.g., publications, models predicting outcome) will be dedicated to the public and will be free for everyone to use. Manuscripts describing results from this project will first be published in the OPTICS volume in an open-access online journal. One of the goals of the project is to encourage collaborations among industry and academia, including those that will exist outside traditional disciplines, such as econometrics and computer science. The OPTICS project will provide a web-based workspace in which such collaboration can occur, and groups with similar methods and research topics will be encouraged to work together.
The OPTICS project is one part of a larger effort at Janssen and other Johnson & Johnson research companies to share clinical trial data to enhance public health, advance science and bring innovative medicines to patients faster. In 2014, Janssen announced a novel agreement in which YODA serves as an independent body to review requests from investigators and physicians seeking access to anonymized clinical trial data owned by the company. This collaboration was expanded in 2015 to include data from clinical studies on medical devices conducted by other Johnson & Johnson subsidiaries.
The OPTICS project is governed by an Advisory Board comprised of scientists from academia, the biopharmaceutical industry, and the NIMH.
For more information please visit https://sites.google.com/site/opticsschizophrenia/.