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The missing link: Blockchain in clinical data management

Published on 14/06/19 at 10:59am

Louis Goss explores the potential uses for the much-hyped technology blockchain as a tool to tackle the data management challenges faced by the pharmaceutical and life sciences industries

On 10 February 1996, the supercomputer Deep Blue checkmated world champion chess player Garry Kasparov. The two-hour game became the first instance of a reigning world champion being beaten by a machine.

Having lost the first game, the Russian grandmaster did manage to win out overall, beating IBM’s original Deep Blue computer 4-2 in a match of six games.

An improved version of Deep Blue – unofficially nicknamed ‘Deeper Blue’ – returned with a vengeance the following year. On 11 May 1997, an upgraded Deep Blue beat Kasparov again, this time securing an overall victory of 3½-2½ in a match of man against the machine.

For many, the six-game match of 1997 demonstrated computers’ superiority over the human brain – at least in the systematic, rule-based world of chess.

However, Kasparov – considered by many to be the greatest chess player of all time – remained in doubt. The grandmaster called into question IBM’s integrity, suggesting he had seen an all too human creativity in the strategy of the machine.

The chess champion demanded printouts of Deep Blue’s log files. IBM refused. Some – including Deep Blue programmer Douglas Murray – even argued a ‘bug’ in Deep Blue’s software had been responsible for a particularly pivotal move.

Nevertheless, Deep Blue’s victory showed clearly the power of ‘brute force’. The unwavering, unrelenting and unemotional machine had triumphed not through strategical insight but instead through its ability to search through billions of possibilities and make advantageous moves.

As said by Kasparov himself: “For machines to beat humans, it doesn't have to be perfect, it just has to make less mistakes than a human. Humans eventually get less vigilant and make mistakes from tiredness. Machines don’t.”

‘Data is the new oil’

In 2006, data scientist Clive Humby, the architect of Tesco’s Clubcard, said: “Data is the new oil. It’s valuable, but if unrefined it cannot really be used. It has to be changed into gas, plastic, chemicals, etc. to create a valuable entity that drives profitable activity.”

Humby’s assessment has been bastardised since first being said; his original insight transformed into the unconvincing aphorism, ‘data is the new oil’. However the sentiment is as true now as it was then – data are useful only to the extent that they can be used to inform decisions in the real world. In other words, data are valuable only to the extent to which actors can ‘mine’ valuable knowledge and then use that knowledge to improve the decisions they make.

The extent to which this valuable knowledge can be extracted is reliant on the ability to access and trawl through huge amounts of data and identify patterns and trends. In order to do this, data must be stored and managed in an easily accessible and systematic way.

In the past, almost all information was stored on pieces of paper. This meant information was hard to access and easily lost and destroyed.  While the storage of this data involved the physical occupation of large spaces in archives and office buildings, the task of trawling through that data involved actually being in the same room as the very papers on which those records were stored. To make things worse a flood, a fire, a thief or any other form of physical threat could in an instant permanently destroy this data, along with the valuable knowledge that information may have held.

With the advent of computers, everything changed. Huge quantities of data could now be stored on virtual databases that occupied a fraction of the physical space which would be taken up by any other means of storing that information. This data also became very easy to copy and transfer.

This newfound ability (to almost instantaneously access information) transformed the role of the analyst who was now in a much better position to draw conclusions from a much larger and ever-growing pool of data from around the world.

This ability has transformed the pharmaceutical sector, which, as an innovative, R&D-focused industry, uses data in almost everything they do.

Bitcoin

In the wake of the financial crisis in 2008, an anonymous computer programmer – or possibly a group of programmers – going by the name ‘Satoshi Nakamoto’ published a description of an electronic currency called bitcoin, in a paper titled Bitcoin: A Peer-to-Peer Electronic Cash System. After posting the paper to cryptographic mailing lists, the anonymous Nakamoto released bitcoin, as open source software, in 2009.

In developing bitcoin, Nakamoto sought to create an electronic payment system that could allow individuals to transfer money to each other, without the oversight or interference of a financial institution or central bank.

As said in Nakamoto’s white paper: “Commerce on the Internet has come to rely almost exclusively on financial institutions serving as trusted third parties to process electronic payments. While the system works well enough for most transactions, it still suffers from the inherent weaknesses of the trust-based model. Completely non-reversible transactions are not really possible, since financial institutions cannot avoid mediating disputes. The cost of mediation increases transaction costs, limiting the minimum practical transaction size and cutting off the possibility for small casual transactions.”

Thus, in setting up an alternative form of payment, Nakamoto developed blockchain, a decentralised, public ledger (or database) which records information in a permanent way. Unlike a centralised database, in which information is stored in a single location under a single authority, information stored on the blockchain is distributed across all of those using the system. The data stored on the blockchain ledger are stored permanently, and cannot be changed without the agreement of the majority of all users. In 2017, researchers from the University of Cambridge estimated that there were between 2.9 and 5.8 million unique users. As such, millions of users would have to agree to make any form of alteration – even the addition of a single comma – to the blockchain ledger.

Nakamoto used blockchain to keep a record of bitcoin transactions. In doing this, the blockchain keeps a record of all new bitcoins and bitcoin transactions on a database stored on all of the computers running bitcoin software. With these facts, permanently stored on an unchangeable database, which is shared across a network of computers, the blockchain can track how much bitcoin any particular individual has at any one time. The information stored on this ledger is open to anyone interested in viewing it.

This ledger is updated every 10 minutes as new ‘blocks’ (records of new accepted transactions) are added to the blockchain. This continuous process of record keeping is carried out by so-called ‘miners’ who are rewarded with newly created bitcoins in return for their work. These ‘miners’ thus form a decentralised network of mints and auditing firms for the online currency.

However, as a currency, bitcoin has not yet achieved the mass appeal necessary for it to become mainstream. Price volatility, which has seen the price of one bitcoin increase from around $200 in 2015 to nearly $15,000 at the end of 2017 and back again to around $5,500 today, has made transacting in bitcoin increasingly difficult. Thus, while bitcoin is accepted as a form of payment by a number of major firms, regulators in the US currently call bitcoin a ‘commodity’.

Blockchain

However, blockchain technology – separate from bitcoin – has shown greater potential. This is especially true in the case of the pharmaceutical industry. In September 2018, a Pistoia Alliance survey of 170 pharmaceutical and life science professionals found that 60% of respondents were either using or experimenting with blockchain technology. This was up from 22% the previous year.

Respondents said they saw potential for the use of blockchain in the medical supply chain (30%), electronic medical records (25%), clinical trials management (20%), and scientific data sharing (15%). Meanwhile, transparency and the immutability of data were cited as the most significant advantages of blockchain technology.

In regard to the medical supply chain, blockchain could increase transparency and ensure the reliability of information relating to medical supplies in transit. For example, information as to the location, temperature, and general condition of a package containing medical supplies could be uploaded to a blockchain ledger, which would then be easily accessible at all times to all parties who seek to know. This could help ensure the traceability of a package of medical supplies and in turn allow for greater accountability in the pharmaceutical supply chain – thus helping to counter falsified, substandard and unregistered drugs.

Those taking medicines would be granted easy access to an unchangeable ledger in which they could read the entire history of the medicine they were about to consume. Through cross-referencing cryptographic signatures, patients would thus be able to confirm that the medicines they were taking were from legitimate vendors. These vendors would in turn have recorded the temperature and humidity at which the package had been stored, and uploaded this information to the blockchain ledger for the patient to read.

Equally, blockchain ‘smart contracts’ could allow for greater efficiency within the supply chain itself. In essence, a smart contract uses blockchain to automatically execute the terms of a contract. For example, a smart contract could automatically pay for the deliveries of active pharmaceutical ingredients as soon as they are delivered to a manufacturing plant.

A record of this transaction would be documented automatically on an unchangeable blockchain ledger, thereby allowing the parties involved to know, almost immediately, when the delivery had been made. While acting to cut out bureaucracy, the smart contract also increases transparency, minimising the potential for disputes.

Applications in data management

In simple terms, blockchain is a database. It is unique in that it keeps and maintains a permanent and unchangeable record of an ever-growing list of timestamped documents. These records are held across a network of computers. As a database, these unique qualities can be advantageous in a number of ways.

Advocates argue blockchain could increase integrity, openness and security when it comes to storing data. For example, a study published in the journal Nature Communications outlined a proof of concept method of ensuring the integrity of clinical trial data.

Essentially, researchers would upload clinical trial data to a blockchain platform, thus ensuring it could not be changed or destroyed. Any additions to the record would be marked with a timestamp and cryptographic signature, thus allowing others to know who had made the additions and when they had been made.

With all parties interacting through this blockchain network, the technology could allow for greater transparency and greater integrity of the data being stored. Researchers would upload data directly to the blockchain, which would then be stored in a permanent and immutable way. This would ensure that from the point at which the data are entered into the blockchain they had not been tampered with, corrupted or changed. It would also ensure that that data could not be lost or destroyed. This may be particularly useful in facilitating multi-organisation partnerships.

However, blockchain does little to address the problem of ‘bad data’ – i.e. inaccurate, erroneous, incomplete or inconsistent data – a problem which costs US businesses more than $600 billion a year. The unification of scattered and fragmented databases through blockchain may go some way to consoling inconsistencies. Still, blockchain does not prevent or address the entry of badly measured datasets.

Nevertheless, blockchain technology could be used to increase access to data (this could help root out errors and inconsistencies). Researchers could upload data to an open blockchain ledger, which could then be accessed by researchers or any other interested party, from around the world. The data uploaded would be automatically timestamped and signed cryptographically, and thus traceable back to the source.

Furthermore, blockchain could help to improve cybersecurity. With data stored on unchangeable ledgers, spread across a decentralised network of computers, the technology would prevent bad actors from corrupting or destroying data. The potential this technology holds is only increased by innovations in ‘permissioned’ distributed ledgers, which act in the same manner as other blockchain ledgers but allow only those with passwords or permission to access the data stored inside.

Similarly blockchain technology may act as  a means of preventing Distributed Denial of Service (DDoS) attacks – cyberattacks through which bad actors overload servers with junk requests. In the past, cyber criminals have used DDoS attacks to demand ransoms – often in the form of bitcoin – from those with assets online. The distributed nature of blockchain technology means it would be nigh on impossible to target every node and thus sustain an effective DDoS attack.   

All in all, blockchain technology offers a secure, transparent and efficient tool for the storage of data. From stock inventories to data from clinical trials, the blockchain provides an unalterable and incorruptible means of keeping record of the information that is vital to the everyday functions of a pharmaceutical company.

Knowledge is not the new petrol

If ‘data is the new oil’, knowledge is not the new petrochemical product. The difference being: petrochemicals are a finite resource. Knowledge is unlimited. While the value in both comes from their utility, in utilising petrochemicals they are destroyed – their use value entirely diminished. In contrast, the value of knowledge is increased through it being shared and used.  

In this sense, knowledge is not a resource to be consumed but rather a tool, used to guide and inform. Now, with the advent of computers, knowledge can be endlessly replicated and endlessly shared. All of this can be done essentially for free. The value of knowledge and information is thus enhanced in this way as the tools we use are refined and improved, allowing for the discovery of new patterns and trends.

As a technology, blockchain can help us to increase our ability to use data through increasing access to, and the transparency and integrity of, the data which are used to improve the systems we use.

Meanwhile, computers have allowed for the analysis and interpretation of this data in increasingly sophisticated ways. With the unrelenting ‘brute force’ of computers – and the new developments in machine learning and AI – the knowledge that can be mined from data continues to grow at an exponential pace.

As such, the pharmaceutical industry will undoubtedly find uses for blockchain and the developments in information technology when it comes to managing and using data. It is the discovery and implementation of these uses that we are tasked with now.

Louis Goss

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