Blockchain technology comprises a major trend in clinical research as it provides a more structured and transparent research methodology by giving a set of hashed metadata that defines the integrity of a clinical trial. It is believed that healthcare communities of patients, medical researchers and caregivers can be built through Blockchain health services. Blockchain confirms optimally secured data flow through decentralized system of servers (nodes).

Current biomedical research lacks reproducibility and holds significant amount of scientific misconduct, errors and frauds; and this all undermines quality of medical research and clinical outcome. Researchers strive for improving the quality of research by empowering researchers with secure data-sharing tool without compromising the privacy of patients. Blockchain technology thus was thought to have good impact on clinical research, as it allows for sharing data through secure peer-to-peer network where tracking dataflow is feasible. Any interaction (view, edit, add, remove) with data from any participant is viewable by all other participants on the system and this has to optimize trust in clinical research.

Blockchain has ever been known as the technology behind Bitcoin, or the distributed ledger where all Bitcoin transactions are recorded without third party processing payments. Accordingly, Blockchain was thought to act as a replacement of traditional banking transaction systems. However, as Blockchain technology provides enormous data storage through its decentralized nodes, it had the potential to be involved with all sectors and industries, starting from governmental voting to healthcare systems and even managing online stores.

Each node (server) on the network is linked to other nodes on the Blockchain, the data are created and owned by one User only who is in full control by giving permission/access to other Users on the network to view or edit these data. Any transaction (event/edit) or update is tracked through inviolability and historicity features of the Blockchain which show the correct chronological order of changes. Cryptography is a third tool in the Blockchain which validates each transaction; validating transactions needs running hashing exercise by miners who run these processes for the sake of crypto-currencies.

The availability of data on the system, with all documents and proofs existing on the Blockchain while being confidential, attracts healthcare stakeholders to invest in such systems and to fund in clinical trials. The data are not limited to clinical trial methodology, statistical analysis and results, but they also contain secondary documents such as patients’ consents, clinical trial protocol, study design and inclusion/exclusion criteria. Future clinical studies can avoid current drawbacks which are believed to comprise a major source of bias such as ambiguous/ insignificant outcomes, under-reporting or mismatched protocol/outcomes. In trusted environments, clinical research teams would be able to recruit more people to become involved in protocols thanks to community-management techniques. For example, Estonia Health authority implemented Blockchain system to restore 1 million health records, aiming to give the ownership and managerial rights to the patient only.

Sharing healthcare information can provide several benefits: setting up datasets of anonymous, analyzable, raw medical data where powerful calculations and strong statistical analyses are applicable will boost the reproducibility of clinical trials and eliminate bias. Blockchain approach can promote secure, large-scale data sharing between permitted entities controlled by the User.

Smart Contracts are computer protocols used to link and validate different terms and conditions of a contract. In this context, in the medical research and clinical trials, Smart Contracts are used to chain together the steps of the trial while giving a high level of transparency and traceability. Smart Contracts are herein applied for solving cryptographed, hashed chains of data and to move from one step to another in successive blocks in order to verify that the designed methodology was followed and that correct execution of the study protocol was conducted.