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Clinical trials often involve many different stakeholders and research sites as well as large flows of confidential data and sensitive information. With more parties being involved and as trials are being conducted further away from sponsoring institutions, comes the opportunity for human-induced errors. These errors can be unintentional, but may also be malicious.

The researchers explain that monitoring and ensuring the integrity of data within the clinical trial process is not always feasible using the technology currently available. This puts a burden on regulators, such as the U.S. Food and Drug Administration (FDA), who are responsible for auditing the data and who are hampered by a lack of data traceability and real-time access to results.

A blockchain-based solution

As an answer to this problem, the researchers propose a blockchain-based system to make data collection in the clinical trial process immutable, traceable, and potentially more trustworthy. As part of the study, the researchers use raw data from a real completed clinical trial, simulating the trial onto a proof of concept web-portal service and testing its resilience to data tampering. They also evaluate its ability to provide regulators with a traceable and useful audit trail of trial data.

“A blockchain-enabled file and data structure could be used to reliably safeguard data in a clinical trials network and provide an immutable and fully traceable audit trail.”

The study concludes that a blockchain-enabled system could indeed offer an improvement in clinical trial data management by bolstering trust in the clinical research process and the ease at which regulators can oversee clinical trials. A blockchain-enabled file and data structure could be used to reliably safeguard data in a clinical trials network and provide an immutable and fully traceable audit trail.



How does this relate to Triall?

In line with Triall’s vision, this study argues that a blockchain-enabled system could be a potential solution to the lack of transparency and traceability of clinical trial data, lack of real-time access to results as they are being made and the potential risk of data tampering.

You may find the article using the following link: https://www.nature.com/articles/s41467-019-08874-y