Aculys Pharma has teamed up with Susmed for what they claim will be the world’s first corporate-sponsored clinical trial using block-chain technology.
The study – details of which were not disclosed – will be carried out using Susmed’s technology by will be conducted by Japan-based contract research organization (CRO) CMIC.
The technology uses blockchain, a linked series of digital transactions in which every detail of each interaction with data or exchange is recorded in a non-editable record.
In this trial the blockchain will be used to bind e-worksheets and eCRF. The idea is to use the system to reduce the amount of data entry work and monitoring work by medical institutions involved in the study.
Susmed also claims the system also contributes to reducing the number of required CRA visits to the medical institutions.
In addition, by taking advantage of blockchain technology the firm says the platform increases the reliability of the clinical trial data itself and that, through these methods, trial-related work streams are made more efficient.
Aculys CEO Kazunari Tsunaba, framed the project as a team effort saying "we expect this pioneering effort of three companies, which aim to improve the quality and efficiency of clinical trials, will realize digital transformation of clinical trial monitoring work and contribute to the optimization of new drug development costs.
“We will continue to actively introduce new technologies not bound by a conventional framework and aim to solve social issues surrounding Japanese healthcare by collaborating and partnering with external partners."
This was echoed by Taro Ueno, CEO of Susmed who said “we believe that utilization of blockchain technology enables us to realize efficient and reliable clinical development and we also can contribute for optimization and sustainability of future social security.”
Susmed’s systems has already been trialed. The system was used in a breast cancer study run in collaboration with Japan’s National Cancer Center, details of which were published in 2020.
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