Evangelatos Nikolaos, Reumann Matthias, Lehrach Hans, Brand Angela
UNU-MERIT, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands.
Public Health Genomics. 2016;19(4):211-9. doi: 10.1159/000446101. Epub 2016 Jun 1.
Knowledge in the era of Omics and Big Data has been increasingly conceptualized as a public good. Sharing of de-identified patient data has been advocated as a means to increase confidence and public trust in the results of clinical trials. On the other hand, research has shown that the current research and development model of the biopharmaceutical industry has reached its innovation capacity. In response to that, the biopharmaceutical industry has adopted open innovation practices, with sharing of clinical trial data being among the most interesting ones. However, due to the free rider problem, clinical trial data sharing among biopharmaceutical companies could undermine their innovativeness.
Based on the theory of public goods, we have developed a commons arrangement and devised a model, which enables secure and fair clinical trial data sharing over a Virtual Knowledge Bank based on a web platform. Our model uses data as a virtual currency and treats knowledge as a club good.
Fair sharing of clinical trial data over the Virtual Knowledge Bank has positive effects on the innovation capacity of the biopharmaceutical industry without compromising the intellectual rights, proprietary interests and competitiveness of the latter.
The Virtual Knowledge Bank is a sustainable and self-expanding model for secure and fair clinical trial data sharing that allows for sharing of clinical trial data, while at the same time it increases the innovation capacity of the biopharmaceutical industry.
在组学和大数据时代,知识越来越被视为一种公共物品。提倡共享去识别化的患者数据,以此作为增强对临床试验结果的信心和公众信任的一种手段。另一方面,研究表明生物制药行业当前的研发模式已达到其创新能力极限。对此,生物制药行业采用了开放式创新实践,其中临床试验数据共享是最引人关注的实践之一。然而,由于搭便车问题,生物制药公司之间的临床试验数据共享可能会削弱其创新能力。
基于公共物品理论,我们开发了一种公有资源安排并设计了一个模型,该模型能够通过基于网络平台的虚拟知识库实现安全、公平的临床试验数据共享。我们的模型将数据用作虚拟货币,并将知识视为一种俱乐部物品。
通过虚拟知识库实现临床试验数据的公平共享,对生物制药行业的创新能力具有积极影响,同时又不会损害其知识产权、专有利益和竞争力。
虚拟知识库是一种可持续且能自我扩展的模型,用于安全、公平地共享临床试验数据,既允许临床试验数据的共享,同时又能提高生物制药行业的创新能力。