Clinical Trial data management faces a number of challenges related to how organisations collect, store and share data. The blockchain offers a solution to these challenges and has the potential to disrupt the way clinical trials will be run in the future.
Clinical trials: a business case for blockchain
Clinical trials are studies that examine whether a medical treatment or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decision-making and we will examine how blockchain can support this process. 1
The blockchain is a globally distributed, universally available ledger of “transactions”. Each transaction is timestamped and verified by every server or node in the network. This ensures that the stored data is immutable and cannot be modified once added to the blockchain. Because the blockchain is globally distributed, the data is not susceptible to hacking. Further more, it is not stored in a central database. The blockchain is widely known as the underlying technology powering bitcoin.
This ledger offers the possibility to track a wide variety of assets, including ownership, identity assertions and proofs, encryption keys, or device attributes among other features. The public blockchain allows anyone to join, read and participate in the adding to the ledger, as is the case for bitcoin. A private (permissioned) blockchain requires opt-in or permission to access, read update the chain, for example MultiChain runs a private blockchain.
Clinical Trial Process
- A pharmaceutical company submits an application to a regulator for a clinical trial. The regulator would review and possibly approve the trial.
- The pharmaceutical company assigns a research team, laboratory or contract research organization (CRO) to manage the clinical trial. This team interfaces with the participants and collects the clinical trial data on behalf of the pharmaceutical company. The trials may collect data through medical exams, tests and questionnaires through a series of phases (Phase I to III).
- The pharmaceutical company analyses the clinical trial data to make an assessment on whether the medical treatment works, The pharmaceutical company submits its findings to the regulator to receive the approval to use/market the medical treatment.
- Finally, the regulator will review the underlying data and together with other processes approve or deny the application.
In each step of the process outlined above, two or more parties interact with a specific set of data that requires verification and validation. This is due to an inherent lack of trust between the players in a clinical trial. Regulators, pharmaceutical companies and patients want transparency about the drugs they are taking. In addition, each step in a clinical trial requires the players trust the data for decision-making. For example, inconsistent information submitted to regulators by pharmaceutical companies in clinical trials is a source of delays and inefficiencies. 2
How can blockchain help?
Blockchain could potentially provide a solution to a number of challenges by creating a shared permissioned record of participants, documents, roles and clinical trial data. It has the potential to foster transparency and trust between stakeholders in clinical trials.
A private blockchain network consisting of regulators, pharma and contract research organisations. 3
The blockchain can provide proof of data integrity during clinical trials. Changes to the previous blocks are not possible, without breaking the chain. In addition, all parties involved in the chain would also see what has changed and who has made the changes. This would likely reduce incidents of error or fraud in clinical trial data recording. Therefore, both the pharmaceutical company and medical regulator can trust the integrity of the data.
The blockchain stores data as a cryptographic hash. Unlocking the data requires matching cryptographic keys. Hence, patients participating in clinical trials can choose to keep their data encrypted to the extent it suits them and only expose relevant information.
The blockchain gives control of the data to the participants in the clinical trials. Patient consent is important when sharing data with third parties. Invalid consent documents, or procedures or general lack of awareness contributes to improper enforcement of patient consent. However, with the blockchain, participants can control when, what, how and with whom clinical data is shared by using smart contracts, which only trigger in specific, pre-defined scenarios.
Is it all hype?
The Gartner hype cycle report advises businesses to prepare for mainstream adoption. This report shows blockchain reaching the peak of hype and is 5 to 10 years away from reaching critical mass. In addition, the report highlights that the expectations for the blockchain are in review, before the increased visibility results in productive use in various industries. Further more, an increasing number of organizations are beginning to experiment with blockchain for example the financial and supply chain markets. It is likely that the pharma industry will also experiment with this technology as it matures.
Clinical trials involves the exchange of data across different stakeholders, and establishing trust among these stakeholders will remain essential. For the pharma industry, the next step will be to design simple models that can be used to educate stakeholders about how the blockchain works, and applying these models to scenarios that can bring business value with the right partnerships.
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- Blockchain in Pharma: Clinical Trial data management - May 17, 2018