当前，药物临床试验面临着两大难题：数据真实性及相关人员操作规范性。现阶段国内外在药物临床试验方面的监管主要以事后监查为主，在数据质量管理以及操作规划标准的监查方面存在一定的时延性。而区块链通过非对称加密、哈希算法及智能合约等技术，可以在保证受试者隐私信息的前提下，提高政府相关监督机构的监管效率，提升药物临床试验数据管理的透明度；同时，与物联网的紧密结合可以实现对标准操作规范的进一步核查，与人工智能的结合有望实现受试者的自动招募。

Clinical drug trials are confronted with two major issues: first, data authenticity, for instance, if any data falsification is conducted during the whole trial; second, whether the standard of procedure is accordingly conducted throughout the whole trial or not. Currently, both domestic and overseas clinical drug trials are not supervised without delay (ex-post inspection). Blockchain technology can improve the efficiency of Food and Drug Administration and the transparency of trials while the rights and safety of human research subjects are guaranteed by the integrated technology such as chained structure, asymmetry key algorithm, hash algorithm, and smart contract. Furthermore, with the assistance of internet of things (IoT) and artificial intelligence (AI), the actual supervision over the whole trial and automatic recruitment of human research subjects are expected to achieve.

近年来，使用人工智能(artificial intelligence，AI)技术对临床大数据及图像进行分析，对疾病做出智能诊断、预测并提出诊疗决策，AI正逐步成为辅助临床及科研的先进技术。生物样本库作为收集临床信息和样本供科研使用的平台，是临床与科研的桥梁，也是临床信息与科研数据的集成平台。影响生物样本库使用效率及合理共享的因素有信息化建设水平不均衡、获取的临床及检验信息不完全、各库之间信息不对称等。本文对AI和区块链技术在生物样本库建设中的具体应用场景进行探讨，展望大数据时代智能生物样本库信息化建设的核心方向。

In recent years, artificial intelligence (AI) technology has been applied to analyze clinical big data and images and then make intelligent diagnosis, prediction and treatment decisions. It is gradually becoming an advanced technology to assist clinical and scientific research. Biobank is a platform for collecting clinical information and samples for scientific research, serving as a bridge between clinical and scientific research. It is also an integrated platform of clinical information and scientific research data. However, there are some challenges. First, clinical and laboratory information obtained is incomplete. Additionally, the information among different databases is asymmetric, which seriously impedes the information sharing among different Biobanks. In this article, the specific application scenarios of AI technology and blockchain in the construction of a Biobank were discussed, aiming to pinpoint the core direction of the information construction of an intelligent Biobank in the era of big data.