Data Security in Clinical Trials Using Blockchain Technology

Data Security in Clinical Trials Using Blockchain Technology

Marta de-Melo-Diogo, Jorge Tavares, Ângelo Nunes Luís
DOI: 10.4018/978-1-7998-7363-1.ch010
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Blockchain technology in a clinical trial setting is a valuable asset due to decentralization, immutability, transparency, and traceability features. For this chapter, a literature review was conducted to map the current utilization of blockchain systems in clinical trials, particularly data security managing systems and their characteristics, such as applicability, interests of use, limitations, and issues. The advantages of data security are producing a more transparent and tamper-proof clinical trial by providing accurate, validated data, therefore producing a more reliable and credible clinical trial. On the other hand, data integrity is a critical issue since data obtained from trials are not instantly made public to all participants. Work needs to be done to establish the significant implications in security data when applying blockchain technology in a real-world clinical trial setting and generalized conditions of use to establish its security.
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Although variations of term have been used before, Blockchain came around in 2008 when this technology was created by Satoshi Nakamoto to support and securely record Bitcoin cryptocurrency transactions (Meunier, 2018; Monrat et al., 2019). Since then, the interest in this technology has increased and soon was applied into other areas of interested such as government, manufacturing, finance, healthcare and distribution (Monrat et al., 2019).

Blockchain is an advanced data structure, designed for storing and sharing information, composed by a growing chain of blocks organized by chronological order (Agbo et al., 2019)(S Chen, Hannah et al., 2019). Each block stores information with digital signatures in a decentralized and distributed network, it allows to record a transaction by binding different blocks connected with chains (S Chen, Hannah et al., 2019) (Abu-elezz et al., 2020) (Monrat et al., 2019). This transaction is validated by a consent algorithm, and therefore, needs no third-party validation to complete an action. The chain continues to grow as new transactions are built and blocks are added into it (Omar, Jayaraman, Salah, Yaqoob, et al., 2020).

Unlike traditional methods, blockchain enables peer-to-peer transfer of digital assets without any intermediaries. All the transactions occur in a decentralized manner that eliminates the requirement for any intermediaries to validate and verify the transactions. Every transaction is regulated by the participants who store and share the information throughout the private key: an unique and individual signature linked to each transaction recorded (S Chen, Hannah et al., 2019).

Key Terms in this Chapter

Clinical Trial: A research study performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention.

Immutability: The state of not changing or being unable to be changed.

Data Security: The process of protecting data from unauthorized access and data corruption throughout all lifecycle.

Blockchain: A decentralized, distributed ledger technology that records the provenance of a digital asset.

Decentralization: The transfer of control of an activity or organization to several local offices or authorities rather than one single one.

Transparency: The quality of operating in such a way that it is easy for others to see what actions or changes are performed.

Traceability: The quality of having an origin or course of development that may be found or followed throughout all lifecycle.

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