Streamlining Clinical Trials

By Michel Goossens

Senior Director, Strategic Initiative Management & Spain/Portugal Site Head at ICON plc

Every day, the internet is used to perform countless transactions. While the internet may seem limitless, the technology, itself, is flawed in that it is not capable of assigning actual ownership of the transacted item, or asset. As a result, we assign intermediaries that can do the ownership accounting for us, such as the bank or website used to perform the transaction. Unfortunately, the use of intermediaries can limit transactions, making them both inefficient and costly. Therefore, a new technology has emerged called blockchain, which has streamlined asset exchange by allowing transactions to occur without this intermediary. Additionally, blockchain creates a public record of transacted items between parties.

The beauty of blockchain is that the digital ledger can be programmed to record not just financial transactions, but also virtually everything of value, including information. Thus, the tech community is beginning to uncover other potential uses for the technology (beyond its claim to fame, the bitcoin), which increasingly includes applications in the healthcare and clinical trial spaces.

Opportunity for blockchain in healthcare and clinical trials

Within the healthcare and clinical trial space, patient data is the most notable item of transactional nature between networks such as healthcare institutions, patients, and regulators. Because blockchain ledgers allow for user confidentiality, patient privacy can be protected during exchange of data between parties. This means that two healthcare institutions can add or access information kept on a blockchain for a single patient without breaching the patient’s privacy. Then, other users within the network also can access this information, such as insurance companies and CROs.

Additionally, blockchain technology allows for complete transparency of data, which has immense potential within clinical trials. Given the impact of products entering the healthcare space, it is important that there is trust in the way that data is produced, transmitted and altered. With blockchain, there is an audit trail built into transaction of data, which allows for verification of the original source of the information being transacted, as well as the ability to detect any attempts to tamper with it.

Finally, blockchain allows for greater data availability. When all data is shared openly within a network, issues with data systems interoperability are reduced, and opportunities open up new possibilities for using that data. For example, in the clinical trial space, availability and accessibility of patient information could be used for patient feasibility analysis and population studies.

Applications in development

Clinical trial efficiency, cost and transparency are some of the biggest challenges in drug and device development, making blockchain a game-changer for streamlining these processes. Thus, there are a number of organisations working towards the development of blockchain in the healthcare and clinical trial space:

  • In 2016, physicians Greg Irving and John Holden from the University of Cambridge performed a proof of concept study utilising blockchain technology. The aim of their study was to increase the trustworthiness of clinical trial results by using blockchain to prevent the selective publication and manipulation of data (1).
  • Professor Antonia Bifulco, in collaboration from Middlesex University, King’s College London and Goldsmiths University in the UK (2,3), developed a new online Computerised Life Event Assessment Record (CLEAR) for a trial measuring stress related to life changes. The project utilised a blockchain to store all trial results on a ledger, which allows for the data to be easily distributed for review and auditing

Navigating digital disruption

Integrating new technologies such as blockchain and other emerging technologies (i.e. machine learning) is a key component to increasing efficiency in clinical trials. However, a significant amount of expertise is required to successfully employ these digitally disruptive innovations into your study. ICON is an experienced partner in digital disruption who can help you navigate the nuances of emerging technologies such as blockchain.

What is Blockchain?

How may this innovation translate to the clinical research industry?

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Sources

  1. Greg Irving 1, John Holden 2, How blockchain-timestamped protocols could improve the trustworthiness of medical science, Retracted article; https://f1000research.com/articles/5-222/v3, but media published: https://www.economist.com/news/science-and-technology/21699099-blockchain-technology-could-improve-reliability-medical-trials-better
  2. (no listed author), Clinical Trial Records Move To Blockchain, March 23, 2016
  3. CLEAR project website