Abstract

Abstract PROBLEM Data quality impacts the validity of results obtained through clinical research due to several reasons. These include degradation of tumor tissue and other biological samples while being transported across large distances. Other concerns related to data collection include breach in patient privacy and loss and corruption of data. Such issues lead to generation of results that are either unreliable or unsuitable for analysis. Blockchain based digital solutions for clinical trials may be an answer to the problem. SOLUTION In this abstract we review one such software ‘Elsy’ that we have used to collect around 1000 samples from more than 70 centres nationwide. Elsy had been deployed on the smartphone and desktop and used by clinical trial teams to plan, execute and monitor the trial across multiple geographical locations. Collection of tumor specimens was monitored from the time the specimens left the operating room by leveraging blockchain technologies. Patient data was imported into the system seamlessly by integration with hospital electronic medical records systems. Customised data forms were mapped to automatically import data fields that were relevant. Once recruited, all patient sensitive data was immediately obfuscated, and a bar code was assigned to the patient, which served as the unique patient identifier. Data was encrypted in transit and at rest on a cloud server, with access requiring 2-factor authentication. Data viewing and editing permissions were tailored to meet patient privacy and security requirements. Changes in data were logged and monitored, eliminating wilful or accidental manipulation of data. AI and ML tools were integrated with the system to perform advanced analysis. CONCLUSION Digital platforms may have the potential to revolutionise the clinical trials systems by enabling the collection of clean and secure data.

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