The COVID-19 pandemic has caused a digital transformation in the medical and research industries with many clinical trials around the world adapting to virtual clinical trials. While virtual clinical trials have many benefits, it can also pose challenges to data integrity and security. That’s where Blockchain comes in. Blockchain technology is a transactional peer-to-peer database that is shared among the nodes of a computer network. It stores information digitally, and guarantees data security without the need for a trusted third party. Information can be recorded and distributed but it can’t be edited.
The groups of data collected are known as ‘blocks’. Blocks have limited storage, and when they are reached they are closed and linked to the older groups of data (blocks) which form a chain of data known as a ‘blockchain’. New data that is collected will be added to a new ‘block’ that will be added to the chain of information once filled.
These blocks of information form an irreversible timeline of data. Each block in the chain is given a timestamp of when it is added to the chain.
How Does Blockchain Work?
Blockchain technology is considered ‘unhackable’ with security features that protect data security. Each blockchain has a public key and paired private key which users utilise to prove their identity and gain access. This ensures that the data is protected. All transactions need to be signed with the user’s private key. An auditing mechanism which operates inside the blockchain allows users to validate whether the sender’s public and private key have been matched.
All transactions taking place in the blockchain can be accessed by other users in the blockchain. This allows users of the private blockchain to see all the previous data that has been collected for virtual clinical trials.
For a virtual clinical trial to work effectively with blockchain technology, there are certain actions that need to happen:
- The clinical trial site, and the clinical trial sponsor provides at least one blockchain block which can be accessed on any electronic device.
- Participants sign up to the system.
- An administrator operates the system for each participating group.
- Participants and administrators ensure that they enter their data correctly.
Benefits of Blockchain Technology
The benefits of blockchain technology include:
- Untouched data: The data in a blockchain system can stay untouched for years and have full integrity. This is important for regulatory processes and whenever cause-effect analyses are carried out.
- Decentralised: Blockchain systems can be used in a decentralised way, meaning that no single entity has exclusive control over the data or its processing. This allows clinical trials to be run anywhere in the world all while achieving similar results and having the same level of data integrity.
- Unhackable: Blockchain is ‘unhackable’ with strict security measures which protect data security.
- Legitimacy: The information in the blockchain can be checked for accuracy to eliminate the risk of inaccurate and biased clinical trials.
- No data breaches: The data found in the blockchain can only be accessed by the person who sent it and the receiver to prevent any data breaches.
- Data consistency: Using the original blockchain in decentralised clinical trials protects data security and participant privacy, ensures correct and consistent data and publicises the information to all the users.
- Chronological record: Whenever data is entered into the blockchain system, the information is recorded and archived. Over time, the system makes a chronological trail of all the transactions that have been recorded.
- Less vulnerable: Because the data is spread across multiple networks of databases in replica copies, the information is much less vulnerable to hacking or stealing.
- Thorough verification steps: Thorough verification steps ensure that the stored data remains intact and protects against unauthorised actions.
- Data received in real time: The data is received in real-time which is crucial for decision making in clinical trials (especially in the case of Serious Adverse Events).
- Integration: The blockchain system can replace traditional and repetitive tasks with smart contracts and e-consent forms. Having a unified platform with multiple capabilities is a huge advantage of the blockchain system.
Challenges with Blockchain Technology
Some of the challenges facing blockchain technology include:
- Good wi-fi needed: Blockchain systems need good wi-fi connectivity to run effectively, meaning that certain places (such as regional areas) may not be able to use this system.
- Data limitations: The blockchain system may not be able to handle the large volume of data being entered into the system. This issue may be solved as technology continues to advance.
- Data is immutable: Once data is uploaded into the blockchain system it cannot be removed. This means that a dangers of insulin use person’s confidential information will be in the system forever – whether they like it or not.
- High costs: Implementing blockchain technology can be quite expensive and require a lot of investment from the companies/organisations involved. The costs include training, managing a team that specialises in blockchain technology, and maintenance.
Utilising blockchain technology can reinforce trust and data integrity in clinical trials, which is especially important as virtual clinical trials are on the rise and more personal data than ever is being uploaded onto computer databases. It allows for real-time decision making to be made and strict governance despite geographical divides, and improves the overall running of clinical trials. Although blockchain technology is relatively new to the clinical trial industry and further development is needed, it has already proven how useful it is.