The OPTICS Project:
Open Translational Science in Schizophrenia
The OPTICS Project is a pilot designed to provide a forum for true translational science based on Janssen clinical trials made publicly available to qualified investigators and NIH data from related studies and trials in schizophrenia made available through the NCBI Database of Genotypes and Phenotypes (dbGaP) and the Schizophrenia data from the NIMH Repository. The aim of this project is to conduct a pilot to demonstrate the value of an open-science approach using pharmaceutical clinical trial and federally-funded observational data to: 1) advance efficacy and safety of medicines for schizophrenia; 2) increase understanding of schizophrenia, including disease natural history, subtypes, and etiologies; and 3) contribute to the development of design and analytic methods for disparate data types, including novel statistical methods and research designs.
This effort is distinct in that it is a time-limited proof of concept for an open-science analytic collaboration based on both clinical trial and observational data sources; it is not the development of a data resource to be used in perpetuity.
The project is governed by a scientific advisory board including researchers from Yale University School of Medicine, Rutgers University, Harvard T.H. Chan School of Public Health, the National Institute of Mental Health (Genomics Branch), and Janssen Pharmaceutical Research & Development. The role of the board is to manage the project and adjudicate the scientific merit of initial proposals and long abstracts submitted at the conclusion of the analysis period.
An open invitation has been issued to researchers worldwide to collaborate in the analyses. All researchers must: 1) meet the data access and use requirements of the data holders; 2) agree that Intellectual property generated from this project will be dedicated to the public and free for everyone to use; and 3) agree that all publications related to this project will first be published in the OPTICS volume.
Collections of Janssen’s paliperidone clinical trials (N=17 trials – the ‘OPTICS Bundle’ on the Yale Open Data Access Project (YODA) site), the NIH genetic/genomic data about schizophrenia (N=10 studies, the ‘OPTICS Collection’ on the NCBI Database of Genotypes and Phenotypes (dbGaP) site) and the Schizophrenia data from the NIMH Repository are being used for these analyses.
Collaborations are encouraged across industry, industry-academic, and outside the usual partners (e.g. econometrics, business modeling, computer science, etc.). OPTICS provides a workspace (web-based) in which such collaboration can occur. Groups with similar methods and/or research topics are encouraged to work together.
The Harvard Catalyst Reactor Program, funded by the National Center for the Advancement of Translational Science (NCATS) has issued an RFA to provide funding for Harvard-affiliated researchers.
At the conclusion of the analysis period (Q1 2017), researchers will meet to discuss results and prepare the publication. Participants who have completed analyses will be invited to attend a meeting at which results are presented and discussed. Groups with similar strategies or research topics will be encouraged to integrate efforts in combined or companion manuscript(s). All results passing peer review will be published in an open-access online journal. Finally, the pilot will be evaluated with the goal of replicating it for other neuropsychiatric disorders.
This is the first time observational 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.
OPTICS project: https://sites.google.com/site/opticsschizophrenia/
Philip Harvey, Ph.D., SIRS Member
The mission of the Schizophrenia International Research Society (SIRS) is to promote research aimed at identification of the causes of schizophrenia, prevention of the illness whenever possible, and treatment of those people who develop the illness. This includes supporting the highest quality research and advocating for increased research funding and increased opportunities (and reduced barriers) for later research. We are a multidisciplinary society, including researchers who identify themselves as psychologists, psychiatrists, neuroscientists, and neurologists. We have biennial meetings and have two high profile journals.
Schizophrenia is a devastating illness with an early onset and substantial disability from its outset. Schizophrenia shortens the lifespan of people affected by the illness by at least 20 years. The cause of schizophrenia is not known and current treatments for the illness do not reduce disability. Thus, research on the causes of schizophrenia, including factors such as genetics and environmental experiences, is critically important. Similarly, research on treatments that reduce disability is also critical. While current treatments aimed at the psychotic symptoms are as effective as treatments in other areas of medicine (such as hypertension), they also produce side effects that may be directly associated with reduced life expectancy. Research on schizophrenia is focused on all of these topics and we support them all equally.