Harry Salivaras: If Blockchain Based, Future Clinical Trials Will Grant Data Privacy and Freedom

Harry E. Salivaras is a young researcher, studying Neuropharmacology at King’s College London. His background and work experiences have been mainly centered around quality assurance and business development in private and public hospitals, the pharma industry and NGOs in in Athens, Greece and the Dominican Republic. He has recently authored a very interesting article on blockchain adoption in clinical trials at King’s Business Review. In the interview below Leo Petersen-Khmelnitski discussed with Harry Salivaras what blockchain adoption may bring to clinical trials in the future.

I have recently done an interview with the head of a repository for clinical databases. When asked about blockchain, he said that he cannot see what blockchain can do with regards to clinical data of what traditional infrastructure cannot do. Can you give him a brief answer?

Blockchain technology, when applied to clinical trials, stands as a more efficient way of storing and sharing data. Overall, it simply aids in instilling more trust between stakeholders (e.g. patients, company, insurance etc.) Arguably, the main difference lies in the way such trust is formed. In traditional legacy data management systems data is centralized; as such, the threat of posteriori data reconstruction, long data inter-party verification times, patient’s not being aware of on-going trials and ultimately even loss of data, are all consequences of having one or few data nodes. Conversely, with blockchain technology, all parties have relative access to the database and as such are more likely to contribute their own health data. Following on, subjects can further have access to insight into the way their data is being leveraged in modern day pharmaceutical/medical research.

In your recent article on blockchain adoptions in clinical trials, you point to three key areas of blockchain that allow for its advantage over traditional legacy data management systems. What are they? Can you explain them to an outsider to blockchain?

The three main axes that I have identified that make blockchain technology a noteworthy approach to improving bioinformatics in the clinical trial setting are: time stamping, timeordering and smart contracting. Time stamping allows for all stakeholders to know when data is being added, modified, or transmitted on the database. Time ordering, is simply the extension of time stamping, resulting in the ordered nature of data. As such, when data is added on the database it becomes immutable; it can always be traced and cannot be deleted. Lastly, smart contracts, allow for ways of managing data with the aid of contractual clauses. This could mean anything from the traditional (if… , then…) statements we see in programming to large decentralized autonomous organizations (DAOs) that allow for a company to be built on such smart contract protocols. All in all, each of these axes serves the purpose of installing greater trust between invested parties.

How do you suggest to apply them in clinical trials?

Time stamping, time ordering, and smart contracts can all be applied in decentralized software programs that will facilitate the exact needs of the organization. For example, all three can contribute to more efficient information management when used in subject recruitment, subject data sharing, and inter organizational partnerships.

Where is the money in blockchain adoptions in clinical trials? Which feature do you see as the largest profit generator? Which one will allow to save most resources?

The monetary gains for companies using blockchain technology in the clinical trial setting can be seen indirectly. One way pharmaceuticals make profits from medicines is by selling the product under the brand exclusive license prior to patent expiration. Patents on new medicines are usually filed prior to the completion of clinical trials. Subsequently, after the filing of a patent, the sooner the clinical trials are finished, the faster the product can be released on the market, and the more time companies have to recoup their investment and make profits. From an application standpoint, this can be achieved by improving patient enrollment. In this manner, clinical trials are less likely to terminate prematurely, with the addition of trials being able to be carried out on a shorter timeline.

Please elaborate on future of consent in clinical trials, how can blockchain help here?

A main area where blockchain technology undoubtably aids in, is obtaining subject consent. With the help of a decentralized data store, the moment a patient decides to consent to the terms and conditions of the trial, a smart contract protocol can be used to obtain all the necessary health data from the subject and eventually allow for subject randomization.

How do you think future payment enrollment may be done if blockchain is adopted to clinical trials?

Payment enrollment is simply another feature that can be implemented using smart contracts. Once certain conditions have been met by both subjects and other stakeholders, the trial subjects are able to receive monetary compensation without the involvement of a third party.

If you were to advice a client who wants to introduce blockchain to clinical trials in his/her company, where will you recommend starting? What to do next?

Yes, I would definitely recommend for clinical trial databases to have more decentralized data nodes. A company could start by recruiting a strong database development team and start introducing features such as the ones mentioned above, to subjects. On the opposing end, companies should also caution possible loopholes in blockchain adoption, such as scalability, stemming from low transaction fees and fast transaction times. These are matters that have not been completely solved in the blockchain industry and are pending development.

Please describe your vision to future clinical trials, with blockchain, AI, big data, IoMT

Looking forward, clinical trials in 10 to 15 years are likely to look completely different from the traditional bioinformatics protocols we are used to nowadays. Mainly, the first key difference includes being able to have databases that serve the same purpose without having additional parties that burden companies with extra costs and take more transaction time. Companies are looking for ways to grow in more simple manners, they are looking to simplify logistical processes in the name of efficiency. Secondly, AI and IoMT can be seamlessly incorporated in smart contract protocols to filter out data outliers identify possible subjects and overall broaden the capabilities of smart contracts. It is highly probable, clinical trials of the future will end on shorter time frames, allowing pharmaceuticals to recoup their investment sooner. Standing as safer data stores while ensuring data validity and immutability will further prove critical to their adoption in the healthcare industry; however, most importantly, the clinical trial setting of the future will hopefully grant subjects the data privacy and freedom they deserve.