The immutable and blockchain driven data will tackle key healthcare challenges. In particular, the field of data integrity, traceability, and accountability can be revolutionized by clinical trials. The data and its analyzes are used to determine the benefits/risk balance of the therapeutic product by stakeholders such as patients, researchers, and regulators. In that case, the principle of “trust” is extremely important amongst all stakeholders.
In addition, FDA (FDA 801) regulatory bodies and NGOs (WHO with its declaration of April 2015) are forcing organizations to report the clinical trial outcomes publicly.
Thus, pharmaceutical firms are seeking new mediums for clinical research and data certification.
Block chain a clinical trial solution
One such platform is Blockchain technology. It is a confidence facilitator by its nature. The decentralized storage of data prevents its change, even if it is open to all stakeholders, by any intermediary or third party at any time. In particular with regard to clinical trial results, we can see it as ‘the only source of fact.’
Blockchain Solutions can also promote key success factors including patient participation, regulatory reporting, compliance tracking and secure traceability of data.
Blockchain Technology in Clinical trial
Secure Data Documentation
Although it is possible to store data on the blockchain, large data chunks that occur in a clinical trial can result in increased storage and lower performance. It takes more time and energy to track the transaction, generate the block and block chain querying with large data sets. Any data and data generated in a trial can however be separately saved in a database (Sidechain) and hashed via a SHA (Secure Hash Algorithm). It provides for every document a special and deceptive low-weight signature.In order to ensure the secured verification for all stakeholders, signatures are stored on the blockchain.
Clinical Data Management Reliability
Blockchain has the ability to improve clinical data and processes by means of accountability, confidence and security considerably. In reality, the interest in incorporating blockchain technology in the field of clinical trials is increasing by key pharmaceutical companies.
Regulation of patients’ involvement and approval
Patients are responsive and eager to engage in the healthcare system more than ever. The dedication of patients in clinical trials is also becoming a crucial success factor. The patient may be assured of agreed protocols coded by blockchain smart contracts when he or she permits consent to participate in a trial. Intelligent contracts guarantee that every amendment to a procedure causes a patient’s consent to be renewed. Registered patients are also expected to communicate with study investigators any past or current medical problems. Since no widespread digital record system is available, previous patient conditions have been declared
We can now assume that such a system would automatically allow investigators access to medical records of patients while preserving patients’ digitally informed consent. Entry to medical documents is valid until the patient consents to intelligent contracts. In short, continued updates of the blockchain patient data will promote openness and enhance patients’ trust in trial researchers.
Regulatory authorities reporting
Governments and regulators are responsible to assess, according to the evidence presented by the research inspectors, the advantages and risks associated with the drug tested. In this regard, stakeholders are expected to provide regulators, on request, with all trial records. In this scenario, a blockchain consortium would include regulators, test sponsors, contract research organizations (CROs), etc. It allows them to constantly exchange clinical data with each other and allow regulators to position questions directly on the blockchain. Though trial-relevant data would be open to all stakeholders, it is not because of its non-public nature that this type of blockchain is built with platforms such as Hyperledger.
Legal conformity and monitoring
In the administration of clinical trials, Ethics committees play a significant role. They define and authorize a trial that honors patients and is prudent. Smart contracts from Blockchain will form the basis for Ethics Committee approvals to be securely stored. They are then awarding one version of the protocol with approvals. In addition, an intelligent contract would automatically trigger a renovation of the approval of the Ethics Committee on demands for improvements to the protocol. Ethics committees can monitor patients’ consents and CROs/sporter compliance with their already accepted protocol using a queryable blockchain database such as BigchainDB.
While blockchain technologies in the healthcare sector are still being implemented, our team of blockchain experts will recommend groundbreaking developments, in particular in clinical trials. The development of clinical trials blockchain healthcare applications offers new effective solutions to optimize and simplify complex processes.
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