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The OPTICS Project: An Open-Science Framework for the Analysis of Clinical Trial Data

The OPTICS Project: An Open-Science Framework for the Analysis of Clinical Trial Data

The OPTICS ProcessFIGURE. The OPTICS Process

A CALL FOR RESEARCHERS

Data sharing and data transparency are becoming the new standard in pharmaceutical and medical device science. Sharing of data collected through clinical research maximizes its value to the scientific and clinical communities and promotes follow-up studies of secondary research using existing data. Sharing also minimizes duplication of data collection by allowing novel research questions to be addressed using existing data, which in turn lowers research costs and reduces human subject burden—while positioning clinical trial data as a public good. Importantly, sharing encourages multiple examinations and interpretations of data, which both protects against faulty analyses and contributes to verification, refinement, or refutation of earlier work.

Several recent initiatives have raised awareness of and promoted data sharing and data transparency, including the Institute of Medicine’s report “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks”; the revised data sharing guidance recommended by the Pharmaceutical Research and Manufacturers of America and the European Federation of Pharmaceutical Industries and Associations, US and European pharmaceutical trade organizations; and the recent recommendations on data sharing from the National Institutes of Health (NIH) for supported research.1-5 Each of these initiatives has the potential to ensure that the clinical research community can better leverage existing data resources for scientific purposes, which increases the likelihood that patients and physicians are better equipped with evidence relevant to any research question or clinical decision.

The purpose of this article is to share information about an initiative launched by the Janssen Pharmaceutical Companies of Johnson & Johnson, the Yale University Open Data Access (YODA) Project, the National Institute of Mental Health (NIMH), Rutgers University Medical School, and the Harvard T. H. Chan School of Public Health: the Open Translational Science in Schizophrenia (OPTICS) Project.

The OPTICS Project

The OPTICS Project is a pilot initiative designed to provide a forum for true translational science in schizophrenia research. The collaboration involves clinical trial data from Janssen Pharmaceutical Companies of Johnson & Johnson and studies made available through the National Center for Biotechnology Information Database of Genotypes and Phenotypes (dbGaP) and the NIMH Repository and Genomics Resource (NRGR), all of which are being made publicly available to investigators. This effort is distinct from other initiatives in that it is a time-limited proof of concept for an open-science analytic collaboration using both clinical trial and observational data sources as opposed to the development of a data resource to be used in perpetuity.

The OPTICS Project aims to demonstrate the value of an open-science approach to better understand the efficacy and safety of medicines used to treat schizophrenia and schizophrenia as a disease, including natural history, subtypes, and etiologies. The intent is to contribute to the development of novel research designs and analytic methods for disparate data types that leverage existing data sources.

A scientific advisory board that includes researchers from each of the participating organizations governs the OPTICS project. The role of the advisory board is to manage the project and evaluate the scientific merit of initial proposals and project summary abstracts submitted at the conclusion of the analysis period. Any researcher is eligible to participate in the OPTICS Project, and an open invitation to researchers has been issued worldwide. However, to collaborate, all researchers must:

• Meet the data access and use requirements of the data holders

• Agree that intellectual property generated from this project will be dedicated to the public and free for everyone to use

• Agree that all publications related to this project will first be published as a compendium of articles—the OPTICS volume—in a peer-reviewed, open-access online journal

Researchers who participate in the OPTICS Project will use at least one clinical trial made available in the collection of Janssen’s paliperidone clinical trials on the YODA site (http://yoda.yale.edu/). The OPTICS Bundle contains data from 17 trials with approximately 7000 study participants; data from the OPTICS Collection, which includes schizophrenia genetic/genomic (dbGaP) data from 9 studies with approximately 18,000 study participants; and/or data from the NRGR, which includes 19 studies with more than 10,000 study participants. The Figure shows the OPTICS Project process.

Collaborations are encouraged across industry, academia, and elsewhere, including those in economics, business modeling, or computer science. The OPTICS Project will provide a workspace (web-based) in which such collaboration can occur. Groups with similar methods and/or research topics are encouraged to work collaboratively.

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