The potential of blockchain for clinical trials
The estimated of the value of blockchain technology to the life sciences sector will be somewhere between $3bn (€2.7bn) and $5.6bn (€5.1bn) by 2025, with the former estimate generated by PreScouter, a Chicago-based research intelligence company.
In its full report into the potential impact of blockchain, the company highlighted the advantages that this type of data management could provide to clinical trials.
The report noted that the number of stakeholders involved in the clinical trial process, from the patients to the sponsors to the regulators, and others, makes for a complicated sequence of data sharing.
Further than this, the nature of clinical trial data, which is sensitive and contains patients’ medical information, adds an additional complication. Though the data must be protected, it also must be shared transparently between those involved in the clinical trial.
According to PreScouter, the combination of these factors “are perfect for blockchain technology, or interoperating blockchains, which allows for immutability, scalability, traceability and varied permissive levels for data access.”
Blockchain can be used in this as each ‘block’ contains a real-time list of records, with a timestamp and a ‘hash’, which verifies the provenance of the block in the chain of transactions.
The report concludes that this structure is “resistant to the surreptitious modification of data or its provenance,” whilst also having the option to have open or closed membership to the chain therefore providing privacy.
The challenges
Though the technology offers a good deal of promise, the relative infancy of this type of data sharing comes with a difficulty in tailoring it to the exact needs of the market.
PreScouter suggests that privacy issues and intellectual property rights could be an issue when choosing data permission levels for members on the blockchain.
An additional barrier to adoption could be regulators getting up to speed with the technology and accepting that blockchain technology is appropriate in “proving a challenge due to the technological, work culture and psychological barriers,” the reports reads.
Initial applications
Such potential drawbacks have not stopped a number of industry players from making moves to implement trials of blockchain.
One example cited in the report is that of Boehringer Ingelheim and IBM’s partnership to test its capabilities in trial management. The test case will be implemented in Canada, with a spokesperson from the former company previously telling us that it expects improvement to the speed and quality of the trial.
In addition to this, Alten Calsoft labs recently launched its first blockchain initiative, BioPharma Ledger, to allow companies to engage the platform for the creation of real-world clinical trials.
