The Open Translational Science in Schizophrenia (OPTICS) project: an open-science project bringing together Janssen clinical trial and NIMH data

Marsha A Wilcox¹, Adam J Savitz², Anjené M Addington³, Gary S Gray⁴, Eva C Guinan⁵, John W Jackson^{6

7}, Thomas Lehner⁸, Sharon-Lise Normand⁹, Hardeep Ranu⁴, Geetha Senthil⁸, Jake Spertus⁹, Linda Valeri^{10

11}, Joseph S Ross^{12

13

14}

Affiliations

¹ Janssen Pharmaceutical Research and Development, Titusville, NJ, USA. MWilcox@its.jnj.com.
² Janssen Pharmaceutical Research and Development, Titusville, NJ, USA.
³ Genomics Research Branch, National Institute of Mental Health in Bethesda, Bethesda, MD, USA.
⁴ Harvard Catalyst|The Harvard Clinical and Translational Science Center, Harvard Medical School, Boston, MA, USA.
⁵ Department of Radiation Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
⁶ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
⁷ Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
⁸ Office of Genomics Research Coordination, National Institute of Mental Health, Bethesda, USA.
⁹ Department of Health Care Policy (Biostatistics), Harvard Medical School, Boston, MA, USA.
¹⁰ Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
¹¹ Laboratory for Psychiatric Biostatistics, McLean Hospital, Belmont, MA, USA.
¹² Section of General Internal Medicine and the National Clinician Scholars Program, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA.
¹³ Department of Health Policy and Management, Yale University School of Public Health, New Haven, CT, USA.
¹⁴ The Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.

PMID: 29950580
PMCID: PMC6021398
DOI: 10.1038/s41537-018-0055-7

Review

The Open Translational Science in Schizophrenia (OPTICS) project: an open-science project bringing together Janssen clinical trial and NIMH data

Marsha A Wilcox et al. NPJ Schizophr. 2018.

. 2018 Jun 27;4(1):14.

doi: 10.1038/s41537-018-0055-7.

Authors

Affiliations

¹ Janssen Pharmaceutical Research and Development, Titusville, NJ, USA. MWilcox@its.jnj.com.
² Janssen Pharmaceutical Research and Development, Titusville, NJ, USA.
³ Genomics Research Branch, National Institute of Mental Health in Bethesda, Bethesda, MD, USA.
⁴ Harvard Catalyst|The Harvard Clinical and Translational Science Center, Harvard Medical School, Boston, MA, USA.
⁵ Department of Radiation Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
⁶ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
⁷ Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
⁸ Office of Genomics Research Coordination, National Institute of Mental Health, Bethesda, USA.
⁹ Department of Health Care Policy (Biostatistics), Harvard Medical School, Boston, MA, USA.
¹⁰ Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
¹¹ Laboratory for Psychiatric Biostatistics, McLean Hospital, Belmont, MA, USA.
¹² Section of General Internal Medicine and the National Clinician Scholars Program, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA.
¹³ Department of Health Policy and Management, Yale University School of Public Health, New Haven, CT, USA.
¹⁴ The Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.

PMID: 29950580
PMCID: PMC6021398
DOI: 10.1038/s41537-018-0055-7

Abstract

Clinical trial data are the gold standard for evaluating pharmaceutical safety and efficacy. There is an ethical and scientific imperative for transparency and data sharing to confirm published results and generate new knowledge. The Open Translational Science in Schizophrenia (OPTICS) Project was an open-science initiative aggregating Janssen clinical trial and NIH/NIMH data from real-world studies and trials in schizophrenia. The project aims were to show the value of using shared data to examine: therapeutic safety and efficacy; disease etiologies and course; and methods development. The success of project investigators was due to collaboration from project applications through analyses, with support from the Harvard Catalyst. Project work was independent of Janssen; all intellectual property was dedicated to the public. Efforts such as this are necessary to gain deeper insights into the biology of disease, foster collaboration, and to achieve the goal of developing better treatments, reducing the overall public health burden of devastating brain diseases.

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Conflict of interest statement

M.A.W. and A.J.S. are employed by Janssen Research & Development, LLC. In the past 36 months, J.S.R. received research support through Yale University from Johnson & Johnson to develop methods for clinical trial data sharing, from Medtronic, Inc. and the Food and Drug Administration (FDA) to study issues in post-market medical device surveillance, from the Food and Drug Administration (FDA) to establish the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI), from the Centers of Medicare and Medicaid Services (CMS) to develop measures for public reporting of hospital and physician quality, from the Blue Cross-Blue Shield Association (BCBSA) to advance pre-market evidence generation for medical products, from the Agency for Healthcare Research and Quality, and from the Laura and John Arnold Foundation to support the Collaboration on Research Integrity and Transparency (CRIT) at Yale. E.C.G. and G.S.G., and H.R., were supported by Harvard Catalyst | The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health Award UL1 TR001102) and financial contributions from Harvard University and its affiliated academic healthcare centers. The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Catalyst, Harvard University and its affiliated academic healthcare centers, or the National Institutes of Health. J.W.J., L.V., and S-L.N. and J.S. received support from Harvard Catalyst—The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Science Award UL1 TR001102). The authors assume full responsibility for the accuracy and completeness of the ideas presented.

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References

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The Open Translational Science in Schizophrenia (OPTICS) project: an open-science project bringing together Janssen clinical trial and NIMH data

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The Open Translational Science in Schizophrenia (OPTICS) project: an open-science project bringing together Janssen clinical trial and NIMH data

Authors

Affiliations

Abstract

Conflict of interest statement

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