Nugent Timothy, Upton David, Cimpoesu Mihai
Corporate Research and Development, Thomson Reuters, London, UK.
Applied Innovation, Thomson Reuters, London, UK.
F1000Res. 2016 Oct 20;5:2541. doi: 10.12688/f1000research.9756.1. eCollection 2016.
The scientific credibility of findings from clinical trials can be undermined by a range of problems including missing data, endpoint switching, data dredging, and selective publication. Together, these issues have contributed to systematically distorted perceptions regarding the benefits and risks of treatments. While these issues have been well documented and widely discussed within the profession, legislative intervention has seen limited success. Recently, a method was described for using a blockchain to prove the existence of documents describing pre-specified endpoints in clinical trials. Here, we extend the idea by using smart contracts - code, and data, that resides at a specific address in a blockchain, and whose execution is cryptographically validated by the network - to demonstrate how trust in clinical trials can be enforced and data manipulation eliminated. We show that blockchain smart contracts provide a novel technological solution to the data manipulation problem, by acting as trusted administrators and providing an immutable record of trial history.
临床试验结果的科学可信度可能会受到一系列问题的影响，包括数据缺失、终点指标切换、数据挖掘和选择性发表。这些问题共同导致了对治疗益处和风险的系统性扭曲认知。虽然这些问题在业内已有充分记录并得到广泛讨论，但立法干预取得的成功有限。最近，有人描述了一种使用区块链来证明临床试验中描述预先指定终点指标的文件存在的方法。在此，我们通过使用智能合约（驻留在区块链特定地址的代码和数据，其执行由网络进行加密验证）来扩展这一想法，以展示如何增强对临床试验的信任并消除数据操纵。我们表明，区块链智能合约通过充当可信管理员并提供试验历史的不可变记录，为数据操纵问题提供了一种新颖的技术解决方案。
