The Open Translational Science in Schizophrenia (OPTICS) Project: Janssen clinical trial and NIH data together in an Open-Science collaboration
Creators: name: OPTICS Project
name: Wilcox, Marsha
name: Savitz, Adam
name: Berlin, Jesse
name: Gardner, Jeff
name: Lehner, Thomas
name: Ross, Joe
name: Williams, Michelle
name: Husseini Manji
Publisher: name: F1000Research
Year: 2016

description: Background<br><br>The OPTICS Project is a pilot initiative designed to provide a forum for translational science in schizophrenia.  This is the first time data about the disorder with associated genomic information and data from therapeutic clinical trials is being made publicly available to interested investigators in one place.  The project is based on data from Janssen clinical trials and NIH-funded studies about schizophrenia.  Data are made available through the National Institutes of Health Database of Genotypes and Phenotypes (dbGaP), the NIMH, and the clinical trial data through the Yale Open Data Access Project (YODA).<br><br>This effort is distinct from other initiatives in that: a) it is a time-limited proof of concept for an open-science analytic collaboration based on both clinical trial and natural history data sources; it is <i>not</i> the development of a data resource to be used in perpetuity.  b) Participant researchers have agreed to address at least 1 of the 3 project objectives (below). c) Cross-sector collaboration is encouraged in the project, leveraging analytic and therapy area strengths that exist in different disciplines – e.g. pharma/academic/bioinformatics/commercial (beyond pharma).<br> <br>The Harvard Catalyst Reactor (NCATS funding) issued a request for applications (RFA) to fund researchers to participate in the project.  This program awards grants to support innovative clinical and translational research projects that have a high potential to impact human health. Catalyst-funded teams are currently working with the data.<br><br>Aims<br><br>The aim of this project is to demonstrate the value of an open-science approach using pharmaceutical clinical trial and federally-funded data about schizophrenia and associated genomic information to:	Advance efficacy and safety of medicines for schizophrenia;<br> 	Increase understanding of schizophrenia, including disease natural history, subtypes, and etiologies; and<br> 	Contribute to the development of design and analytic methods for disparate data types, including novel statistical methods and research design<br>Conclusion<br><br>This is the first time data about the disorder and clinical treatment trials are being made available to researchers in one place. The ability to analyze these datasets together enables researchers to address questions about the disease, therapies, and analytic methods in ways not possible before now. <br><br><br>OPTICS: https://sites.google.com/site/opticsschizophrenia/<br><br>Yale Open Data Access: http://yoda.yale.edu/optics-trial-bundle<br><br>NIMH: https://www.nimhgenetics.org/available_data/schizophrenia/<br><br>dbGaP: http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/collection.cgi?study_id=phs000887.v1.p1<br><br><br>We encourage investigators interested in any aspect of the project to apply.