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"The Impact of Blockchain Technology on Clinical Trial Data Integrity" by Karl Cullen

by Finbarr Sheehy | Oct 26, 2020
Ann Maria SunnyClinical trial data integrity is a fundamental aspect that contributes towards successful clinical trial outcomes. Data must be traceable, accurate and trusted. As clinical trials grow, so too does the complexity and quantity of clinical data being produced. Erroneous, incomplete, inaccurate and lack of traceability have been recurring concerns within the industry. Blockchain is a distributed decentralized ledger that contains timestamped records of data inputs that provides full data provenance and transparency while providing full trust in the accuracy and legitimacy of the data. Blockchain possesses the potential to overhaul how clinical data is managed, stored and shared while providing regulators with data that is fully reproducible and representative of the trial.



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The research objectives of this study are as follows;

To gain a deeper understanding of the some of the key issues surrounding clinical research data integrity

To evaluate the current knowledge and awareness of Blockchain within the clinical research industry

To determine the suitability of Blockchain in addressing the key issues surrounding clinical data integrity from a clinical data management perspective through quantitative and qualitative research


A pragmatist inductive approach was undertaken with this study of which the research purpose was considered exploratory. The research method used was a complementary quantitative and qualitative mixed methods approach. The sources of data consisted of an online survey while the sampling methods employed were non-probability and purposive homogenous sampling. A thematic analysis approach was then taken in order to analyze the data produced from the qualitative questions and the quantitative data was analyzed in conjunction with the qualitative data to support one another.

Favor in support of Blockchain-enabled clinical trials was overwhelmingly positive from participants who took part in the study. Participants were chosen who best represented those who would have prior knowledge and understanding of Blockchain, however it was found that not all participants were even aware of Blockchain prior to the study. Blockchain understanding was quite mixed, however, all participants stated they would use Blockchain over legacy data management systems despite in depth knowledge of its functionalities. All participants stated they were aware of ongoing clinical data concerns concerning its integrity and that Blockchain could possess the architectural structure to alleviate those concerns that would benefit all stakeholders from the regulators to the patients.

Although Blockchain has been in existence since 2009 , it has formally been associated with cryptocurrency transactions and therefore it is still a relatively nascent technology still within its infancy of implementation within the clinical industry. While Blockchain is making strides in other industries, it is only beginning to be recognized as a potential platform to manage, store and share clinical data in a secure, transparent and immutable manner. Complexity and lack of understanding of the technology appeared multiple times throughout the study analysis and may act as a possible prohibitory factor towards its potential uses. Participants pointed out the increasing importance for clinical data integrity especially during the Covid-19 pandemic, and highlighted the potential beneficial applicatory functionalities of Blockchain within vaccine research.


It was concluded that there exists extensive data-related issues within clinical research that contribute to a lacking of integrity in the data. There is still a degree of misunderstanding regarding the functionalities of Blockchain as a standalone platform dissociated from cryptocurrencies and there appears to be still a lack of basic awareness of its existence within the clinical research industry. The key conclusion derived from this study was that there are substantial obstacles that must be overcome before the technology could even be considered for implementation. Issues involving GDPR, ownership of data, data privacy, a lack of Blockchain experts and regulatory oversight concerns all must be solved. Blockchain has far reaching benefits not just for data integrity but for many other aspects of clinical research such as improving patient trust, acting as a decentralized repository for clinical data especially within vaccine research and could also be used alongside smart wearables to accurately record an auditable data trail from the point of origin that is fully immutable and tamper-proof.

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