Wilcox Marsha A, Savitz Adam J, Addington Anjené M, Gray Gary S, Guinan Eva C, Jackson John W, Lehner Thomas, Normand Sharon-Lise, Ranu Hardeep, Senthil Geetha, Spertus Jake, Valeri Linda, Ross Joseph S
Janssen Pharmaceutical Research and Development, Titusville, NJ, USA.
Genomics Research Branch, National Institute of Mental Health in Bethesda, Bethesda, MD, USA.
NPJ Schizophr. 2018 Jun 27;4(1):14. doi: 10.1038/s41537-018-0055-7.
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.
临床试验数据是评估药物安全性和有效性的金标准。为了证实已发表的结果并产生新知识，在透明度和数据共享方面存在伦理和科学上的必要性。精神分裂症开放转化科学（OPTICS）项目是一项开放科学倡议，汇集了杨森公司的临床试验数据以及美国国立卫生研究院/美国国立精神卫生研究所来自精神分裂症真实世界研究和试验的数据。该项目的目标是展示使用共享数据来研究以下方面的价值：治疗安全性和有效性；疾病病因和病程；以及方法开发。项目研究人员的成功得益于在哈佛催化剂的支持下，从项目申请到分析的全过程协作。项目工作独立于杨森公司；所有知识产权都奉献给了公众。这样的努力对于更深入地了解疾病生物学、促进合作以及实现开发更好治疗方法、减轻毁灭性脑部疾病总体公共卫生负担的目标是必要的。
