Implementation of Blockchain brought to trust in the medical research by developing the unvarying time in the research findings. In 2008, Satoshi Nakamoto ensured ledger transactions will not change with time. The two main features of data are historicity and inviolability at the functional level. It ensures that the events are tracked in the chronological order, which prevents a synthetic analysis.
By cryptographic validation, the data integrity is ensured on each transaction. The reason behind the data sincerity is limited false data, visual data improvement and upto some level data invention. And each transaction is time-stamped with blockchain. By these methods, the information is visible to all and any user can take a copy of proof of the data kept in the blockchain. There are many such examples present in the clinical trial as they have so much complicated data and metadata flowing through them. And, all the data, document are kept confidential in the blockchain.
The non-exhaustive examples of the Blockchain:
In case any of the Data-sharing plans is disclosed which includes documentation, schedule and agreements then the data can be time-stamped in the order of their occurrence under unfalsifiable blockchain.
All the data is gathered into Blockchain before any trial begins, like clinical trial protocol, consents, also study related to outcomes. This feature of blockchain can help in preventing the clinical trial issues such as outcomes related to selective reporting, Protocol mismatch and endmost publication. All these issues are the sources of bias. The metadata set of the blockchain stores various mode of data, attribution method, withdrawal dates to differentiate the early ones with late ones.
Before the analysis is done, the need for a time-stamped statistical analysis plan is critical. This plan includes all the detail of the events which can harm and adjustments needed to be done. For instance, Sample size is the important point to estimate the power of a study. So, estimation of outcomes by the research team is quite complex and difficult. However, Blockchain provides the time-stamped data on the metadata set with event rate estimation and treatment effect. Time-stamping set a benchmark which testifies to the size of the sample prior.
Phase Control by Blockchain
Besides all the above factors, Blockchain is also capable of dividing the process into different clinical trial steps such that each prior step depends on the next. These steps bring transparency, control, and traceability on the steps. By categorisation Blockchain brought tools for “chain and slice process”. These are called Smart Contracts.
In simple words, Smart contracts are the kind of computer protocols which verify, facilitate and negotiate the contract. The execution of Smart Contracts can be done by cryptographic hash chains. Basically, it validates the step only if the previous step is validated.
For example, A series of successive block verifies the methodology implemented is correct. And these blocks are smart contracts.
Proof for consent collection
To proof this concept, a blockchain system was implemented on a group of 34 people. The reports show that 10% of the trials faced consent issues such as unapproved forms, informed consent, invalid consent document, failure to re-consent, missing review of protocol changes. To be precise, each patient was time-stamped by the blockchain and then again renewed the consent with revised protocol. Then a final master document is obtained that contains a single data structure which is known as Chainscript, all these data are bound to the versions of the protocol (revised versions). However, all the data was “hashed” which are formatted into cryptographic form. Moreover, the master document represents strong and secure proof of the presence of consent-collection process.
Blockchain technology is an emerging technology which is growing faster. The technology can help in bringing the transparency in the process and provide a core set of defined metadata. Apart from all these advantages, there are many other professionals who don’t believe in the information received is accurate and completely fixed. Bitcoin is the perfect example to proof in favor of the blockchain. In fact, the blockchain technology will boom trust by upbringing internet of things, individual granularity, decentralisation, and security. Blockchain certification facilitates all these things plus enhances the capabilities such that the person is well prepared before entering the field and ensure the excellence.
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