The blockchain is all set to disrupt most sectors and the healthcare industry is no exception. Among the specific niches where blockchain has huge potential is the management of clinical health records. Data integrity and transparency is critical in clinical trial applications, and the immutable nature of blockchains is ideally suited for the purpose.
The present model of clinical research data management faces various limitations. Consider a clinical research situation which involves investigating a person’s heart rate. The investigator may monitor the heart rate using a wearable device, collecting and storing the data locally. The data may then be transmitted to a centralized server, usually in the cloud. The chances of the data being disrupted in transit, stolen, or even distorted are high. There are also issues with access rights, especially rights to modify the data. The system is ad-hoc at best, with no universally accepted technical standards.
Blockchain offers a robust alternative, where rather than transmitting clinical data to a remote location, with all the associated risks, it is stored on blockchains. Each block would contain raw data pertaining to the patient’s heart rate at a discrete time point.
With blockchain, data is stored in a series of blocks, using a peer-to-peer (P2P) network. The database thus created is decentralized and distributed, with responsibility for information stored in the database shared among multiple parties. Such a distributed ledger methodology of blockchains offers big improvements in accuracy, privacy-transparency trade-off, and security of clinical data.
Applying Blockchain to Ensure Data Integrity
The most potent advantage of blockchain is data integrity. The only way to modify a block where data is stored is by consensus with all parties involved in the process. Every stakeholder to the data holds a local copy of the shared dataset. A stakeholder seeking to change the data not only needs to establish his identity through a series of rigid cryptographic criteria, but also requires the authorization of every other stakeholder. The edit, once approved, becomes a “block,” or an easily traceable fixed event, approved and locked into place. As new blocks get added, old blocks remain immutable, offering a log of changes, with timestamps. In clinical research, this translates to perfect control over who is allowed to make changes to the data. The risk of any party with a vested interest in the value chain hiding or modifying certain outcome data is eliminated.
Blockchain and Data Security
One of the biggest USP of blockchains is data security. The decentralized nature of blockchains make it immune to theft or attacks, and also improve the traceability of the data.
Blockchain also offers the scope to keep patient data anonymous. The data which emits from wearables and other monitoring devices may be fed directly to blockchains and aggregated into a single trial record available to the public or other stakeholders. The key challenge is establishing proper encryption protocols, with the application of private keys to authorize select networks to access the data.
How Blockchain Improves Data Transparency
Blockchain improves data transparency and offers the perfect transparency-confidentiality trade-off. The technology plays into the need of a reliable, complete, and up-to-date source of information for the stakeholders.
Medical practitioners, patients and industry professionals rely on clinical registries to track historical, ongoing, and planned clinical trials. However, such registries are rife with inconsistencies. Not all information is uploaded, and even the uploaded information may be piece-meal or outdated. In many cases, it is difficult, if not impossible to find information on why certain therapies do not progress past a certain stage. The underlying reason, such as funding issues, safety concerns or anything else may not be disclosed or updated in the available clinical registry. Likewise, the registry may not make implicit potential licensees, investors, and customers.
The application of blockchain technology narrows such knowledge gaps, rendering greater insights and more comprehensive and objective reviews on drug discovery and development.
Blockchain ledger also eradicates data silos which invariably develop when data is stored locally, and often in an ad-hoc manner. Blockchain forces clarity and standardization of data ownership, information governance, and the reconciliation of conflicting changes from multiple sources.
In today’s overriding spirit of openness, it is in the best interests of the life sciences stakeholders, including companies behind the clinical research, those funding the research, and universities conducting the research, to be as transparent as reasonably possible. Transparency increases public trust, which is at an all-time low with big pharma. Those prescribing the drug or remedy can do so with greater confidence and be assured that their choice of treatments have been well-evaluated for safety and efficacy. They can access and verify the data themselves, without being dependent on an uncertain third-party portal.
Blockchain applications offer the potential to move clinical data and research toward a more community-driven process, with all stakeholders providing checks and balances on the development process. The end-result of such a shift would be a better quality of therapies being developed, improved outcomes for patients, and a win-win solution for all stakeholders.