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Blockchain has been one of the biggest tech disrupters in the past year – and industries such as pharmaceuticals and med-tech are realising the potential benefits.

Blockchain is a “distributed ledger” technology – a means of storing transaction records securely, transparently and in a decentralised fashion.

The technology is best known for underpinning cryptocurrencies such as bitcoin — but it’s finding uses in areas such as agriculture and medicine because of its ability to secure supply chain data.

In order to alter a database, a key is required, which can only be validated by multiple levels of encrypted algorithms – meaning that once records are created, they cannot be modified or deleted — only added to.

Aussie biotech Actinogen’s Senior Director of Clinical Development and Strategy, Tamara Miller, believes the technology could be a game changer in drug development by broadening access to patient data.

ASX-listed Actinogen (ASX:ACW) is testing a unique treatment for Alzheimer’s disease.

“Through blockchain, there is the potential for anonymised patient data to be accessed securely, enabling drug developers to rapidly identify the right kind of patients,” Ms Miller told Stockhead.

“Recruitment is often the number one challenge in timely completion of a clinical trial. Up to 80 per cent of global trials are delayed due to difficulties in patient recruitment.

“If you consider that the process to get a new drug approved often takes on average eight years and billions of dollars, reducing those numbers by any degree is significant.”

Actinogen’s Senior Director of Clinical Development and Strategy Tamara Miller

Digital records

Medical records stored via blockchain could help researchers quickly find the exact patient types required for a clinical trial — reducing or even removing lengthy, manual processes.

Actinogen has so far been successful in recruiting half of its required pool of patients in its Phase II XanADu study in Alzehimer’s disease. But finding acceptable study patients isn’t as easy as it might seem.

Most studies start with their own isolated databases. A large initial pool of patients can quickly wither down to single digits through a huge funnel of clinical trial exclusion criteria:

“We are on track at the moment but keeping on top of patient recruitment comes at a significant time and personnel cost and is something that is front of mind daily.”

The value of digital health records was highlighted in the budget earlier this week with $5 million over two years to be spent on giving all newborn Australians a lifelong electronic health record.

That’s in addition to its current rollout of MyHealthRecord through the Australian Digital Health Agency, an initiative that has been exceedingly slow in uptake and widespread implementation.

Factoring in similar initiatives globally, that does though make for a wealth of untapped information– just waiting for a blockchain solution to ease individual’s, carer’s, professionals’ and government’s minds that privacy and confidentiality of such data can be ensured.

Clinical trial application

The technology has implications further in the processing of results – what could open opportunities for important clinical study results to be shared amongst drug developers, setting down company lines to strive toward a cure.

“At present, there is no central repository of information when it comes to Alzheimer’s disease – despite hundreds of projects in the space at any one time,” Ms Miller told Stockhead.

“If we only had the secure networks to share data we could have a significantly wider data pool to draw from, enriching drug development programs and ultimately providing better and faster solutions to unmet medical needs, such as safe and effective Alzheimer’s treatments.”

There are multiple valuable Alzheimer’s data registries available currently, but they are largely academic-focussed and the information contained represents only a fraction of what could be shared.

Blockchain’s ability to anonymise data would provide a means to give away detail without sacrificing IP; multiple levels of access to study data could be implemented, opening up a new market for data mining within the drug development industry.

“It may give R&D departments the chance to mine data in the initial stages of trial development – enabling tailoring of study designs to mitigate risk, so we aren’t making the same mistakes that have been made before us,” Ms Miller said.

From an operational perspective, clinical studies are usually performed utilising various different software provided from third parties using off-the-shelf systems and isolated platforms; –access to such disconnected systems provides little benefit to the drug development process.

“Transparency and accessibility across all platforms used would enable enhanced collaboration between the different vendors involved in a clinical study, and it seems that only blockchain has the ability to maintain the privacy and integrity of such data.”

Tech transition

It is important to remember this is all within an industry that historically relied on paper records and largely still does- medical prescriptions are still printed and patient charts and records at hospitals are largely paper-based.

In clinical trials, as few as 10 years ago case report forms (CRFs) were still paper-based, and the transition from paper to electronic CRFs (e-CRFs) took a significant amount of time to adopt, facing resistance and technophobia.

The change it delivered though to the industry was immense – saving time, money, and ultimately delivering a vastly superior experience in data capture and reporting in clinical trials.

“It has taken until now to have complete adoption of eCRFs but hereafter, the next advances in technology to aid clinical trials would almost certainly be met with open arms,” Ms Miller said.

“The curve of widespread adoption of tech in clinical trials has passed, it doesn’t matter now what the supporting infrastructure looks like on the back end, as long as the tech provides time and cost benefits, whilst maintaining the privacy and integrity of data, it will be embraced.”

 

This special report is brought to you by Actinogen.

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