Blockchain protocols in clinical trials: Transparency and traceability of consent.
Blockchain protocols in clinical trials: Transparency and traceability of consent.
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DOI：
10.12688/f1000research.10531.5
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发表时间：
2017
期刊：
影响因子：
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通讯作者：
Ravaud P
中科院分区：
文献类型：
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作者：
Benchoufi M;Porcher R;Ravaud P
临床试验协议及其修订的同意对于患者应该是透明的，并且对于利益相关者来说是可追踪的。我们的目标是实施一个允许收集患者知情同意的流程，这与协议修订有关，以安全、不可伪造和公开可验证的方式存储和跟踪同意，并实现实时共享该信息。为此，我们使用称为区块链的趋势技术构建了同意工作流程。这是一种分布式技术，带来了内置的透明度和可追溯性层。从更普遍和前瞻性的角度来看，我们相信区块链技术给整个临床研究领域带来了范式转变。我们设计了一个概念验证协议，其中包括使用区块链对患者同意收集的每个步骤进行时间戳记，从而通过加密验证以安全、不可伪造和透明的方式对同意进行存档和历史记录。对于每个协议修订，都再次征求同意。 我们获得了一份开放格式的文档，该文档说明了整个同意收集过程：关于每个协议版本的带时间戳的同意状态。该文档不会被损坏，并且可以在任何专门的公共网站上进行检查。它应该被视为可靠的数据证明。然而，在现场临床试验中，应该加强认证系统，以消除对第三方（这里是试验利益相关者）的需要，并给予同行用户参与控制。未来，可以使用区块链来跟踪临床试验的复杂数据流，其核心功能称为智能合约，可以帮助防止临床试验事件不按正确的时间顺序发生，例如在患者同意之前将其包括在内，或者在冻结数据库之前分析病例报告表数据。在全球范围内，区块链可以帮助提高可靠性、安全性和透明度，并且可以成为实现可重复性的一致步骤。
Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again. We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a consistent step toward reproducibility.