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Blockchain technology in the clinical trials area

Many people came across Blockchain technology through one of its financial applications known as Bitcoin. However, this decentralized, timestamped and non-hackable source of cryptographically chained data may solve some key challenges in other areas such as healthcare, and especially clinical trials, a field where data integrity & traceability and transparency are of highest importance. Patients (and therefore the public), researchers, industry and regulators rely on this data and its analysis to assess the benefits/risks balance of a therapeutic product: in this case, the notion of “trust” between all the stakeholders reaches its height.

As the pressure of regulatory bodies (FDA with FDAAA 801)1 and NGOs (WHO with April 2015 declaration)2 to publicly disclose clinical trials results is increasing, pharmaceutical companies are investigating new ways of certifying clinical trials and data, with blockchain technology being one of them3. Blockchain technology is trust-enabled by design: its’ decentralized nature associated to the cryptographically encoded data chain prevent its alteration by any third party while being available to all stakeholders at any time and may be considered as the “single source of truth”, especially when it comes to clinical trial data. Moreover, this technology also enables key success factors such as patient engagement, reporting to regulators, ethical & compliance oversight and secure data tracking.

Overview of Blockchain’s application for clinical trials

Patient Engagement

As patients are becoming more and more attentive and willing to play a role in their health care, patient engagement is becoming an ever-increasing success factor for clinical trials4.From informed consent signature to protocol adherence, patients are the cornerstone of any medical study. When giving consent to participate in a trial (through a blockchain transaction), the patient is assured he/she agrees to the protocol encoded in the blockchain and the smart contract feature ensures that any protocol modification triggers a patient consent renewal5.

Enrolled patients are also required to share any past or current medical conditions with the study investigators and while no generalized digital health record system is available, previous patient conditions are based on declaration which may be inexhaustive and inaccurate. Taking into consideration the recent Estonian experience6, where 1.3 million residents benefited from a blockchain-enabled e-Health record system, one could imagine that the digital informed consent signature of a patient to enrol into a clinical trial would automatically grant investigators access to the patient medical record, including documents. This access would be guaranteed as-long-as the patient gives its consent thanks to the smart contract feature, thus leading to exhaustive patient information. Furthermore, continuous logging of patients’ data on the blockchain enables transparency and enforces patients trust into trial investigators.

Reporting to Regulators

Government regulators must assess the benefits / risks of an investigated product based on evidence exhibited by the trial investigators. Good clinical practice states that all trial-related documents must be made available upon regulator request. The implementation of a consortium blockchain driven by the regulator, the trial sponsor, the Contract Research Organizations (CROs) and other involved healthcare organizations would allow the continuous sharing of clinical data between these entities while allowing regulators to directly log queries on the blockchain. Trial-related data would therefore remain accessible to all the stakeholders while remaining confidential thanks to the non-public nature of this type of blockchain. As regulators and the WHO are enforcing regulations to disclose the results of any clinical trial (FDAAA 801 and WHO 2015 statement), the number of completed studies with published results remains relatively low (>30%). This number could be increased as the trial results would be embedded on the blockchain, hence reinforcing transparency and trust between all stakeholders.

Number of completed clinical trials vs number of trials with published results7

Ethical & Compliance Oversight

Ethics Committees play a crucial role in clinical trial management as they approve the trial protocol as being safe and respectful for patients. Blockchain and smart contracts are able to provide the perfect canvas for Ethics Committees to cryptographically acknowledge and store approvals. Approval would only be granted for one version of the protocol and in the same manner, any protocol modification would trigger an Ethics Committee approval renewal. Using blockchain queries, Ethics Committees could also keep track of patients informed consents and adherence of sponsor/CROs to the previously approved protocol.

Secure Data Tracking

While storing data on the blockchain is possible, storing large data sets similar to those generated during the course of a clinical trial may lead to increased storage costs (all data is decentralized and each node will have an individual copy of the data) and lower performance (transaction check, block generation and blockchain querying with large sets of data will take more time & resources). Nevertheless, any document generated during the course of a trial may be stored on a separate database and hashed using SHA (Secure Hash Algorithm) to provide a unique and tamper-proof signature for each document. This low-weight signature may then be stored on the blockchain to provide a secure data tracking for all stakeholders.

Storing a document signature on the blockchain in association with an external database

Storing a document signature on the blockchain in association with an external database

Disrupting Clinical Data Management & Transparency

The blockchain technology has the potential to disrupt clinical data management and transparency processes. However, the low maturity of this technology in the healthcare domain is a hurdle that yet needs to be overcome. As pharmaceutical companies are showing a growing interest for the implementation of blockchain technology in the area of clinical trials, collaborations with technology companies are increasing over years to leverage this ledger technology. One example is the recent partnership between Boehringer Ingelheim and IBM in Canada “to test whether blockchain technology in clinical trials provides a decentralized framework that enables data integrity, provenance, transparency, and patient empowerment as well as automation of processes, ultimately improving trial quality and patient safety at reduced cost.” 8

Author :

Aymeric Colleville, Senior Consultant Life Sciences

With the participation of Véronique Fassy, Partner Life Sciences