A Concrete Way to Develop Clinical Research in a Fair Way to the Users/Patients Using Blockchain Technology

A Concrete Way to Develop Clinical Research in a Fair Way to the Users/Patients Using Blockchain Technology

João Fonseca-Gomes, Denise Francisco, João Mota Sequeira
DOI: 10.4018/978-1-7998-7363-1.ch009
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Blockchain is being explored as a potential solution to many problems in areas other than the one created initially: cryptocurrency. Blockchain technology allows the authenticity of data, security in transactions, and privacy without the need for a third party. For that main reason, one of the growing interests concerns its application in healthcare, namely in clinical research. Multiple pain points of clinical research might benefit from the implementation of blockchain technology. This chapter shows some examples in which this technology is already implemented, identifying the advantages of its use. One of those advantages is clinical research, with the possibility of the patients managing their own clinical data and being properly rewarded for that. Research about clinical data monetization for patients is currently limited, and this chapter also proposes a hypothetical scenario of health data monetization workflow.
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Blockchain Technology Overview

In October 2008, Satochi Nakamoto introduced a peer-to-peer electronic cash system: The Bitcoin (Nakamoto, 2008). He/she proposed a way to make transactions between two parties without the need of going through a financial institution. Nakamoto realized that digital signatures would not solve the need of a trusted third part to avoid double-spending transactions. The solution proposed was a peer-to-peer network. Timestamps transactions hashed and saved on an ongoing chain former a record of data that can no longer be edited or removed (Nakamoto, 2008). Although it was been explored in other systems, to date, cryptocurrencies are still the most commonly recognized use of blockchain technology. This technology have been described in several ways, the most generally accepted is: a peer-to-peer (P2P) distributed ledger technology (Laure A. Linn, 2016). This means that blockchain works as a system where each member in the network (node) stores an identical copy of the ledger. Each node gives their contribution on the collective process of validation and certification of the data recorded. The advantage of this decentralised P2P architecture is the lack of a central server to guarantee trust. When happens to occur a record of a digital transaction it has to be evaluated through algorithms by each member of the distributed network. The update of a new transaction on a shared ledger occurs only if the majority of the members vote as a valid process. When a consensus is reached all the other nodes updated themselves and that information can no longer be edited or deleted.

The security of the process is guarantee through the usage of cryptographic keys and signatures. Privacy is protected in the blockchain using a system of a key pair for each member: a public key and a private key. Zhuang and colleagues refer to the private key as a signature and a public key as a bank account. To understand how this key pair works, a new transaction by an user might be considered. All the other members of the blockchain can see the public key of that user, but it keeps the private key hidden. Although the private key is not accessible, it is possible to check if the public key and the signed private key of the transaction match. If they not match the transaction will be voted down by the users and discarded. (Yan Zhuang et al., 2019) In addition, to being digitally signed the information contained in the transaction is encrypted to guarantee authenticity and accuracy. Transactions are stored into blocks that are added in a chronological order to a chain. Each block contains a unique code called hash. It also contains the hash of the prior block of chain (Laure A. Linn, 2016). The overview of the process is schematized in Figure 1.

Key Terms in this Chapter

Data Monetization: Process of using data to obtain economic benefits, which includes, not only the cash flow in (data selling), but also all the actions that brings value to the company.

Clinical Research: Study of health and illness in people, including not only the translation of pre-clinical studies (basic research) into clinical ones, but also the scientific groundwork for prevention, diagnosis, and treatment of pathologies.

Smart Contract: A contract programmed with protocol codes that are self-executable stablishing restrictive rules in the same way of the traditional contract document. It has obligations, benefits, or penalties for all the parties involved.

Chain Value: A business model that describes the set of activities that a company carries out to deliver a valuable product or service in order to generate value.

Big Data: Data rapidly generated, in large scale and from multiple sources, mainly characterized by the 3 Vs: Volume, Velocity, and Variety.

Clinical Trial: Set of studies focusing the demonstration of safety and efficiency (without relevant side effects) of a particular medication and/or medical device, being an obligatory requirement before accessing the market.

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