Medical Research

The Right Medicine. Bringing blockchain technology to bear… | by Mike | Dec, 2021

Mike

Bringing blockchain technology to bear on real-world problems

As an Authority Node Operator(ANO) for the Factom protocol it is always very interesting to see new projects utilizing the benefits of this blockchain. One that has recently launched is Triall, whose use of decentralized ledger technology to help solve medical research challenges is pioneering. This brief blog post explains the function & benefits of the Triall protocol and why we are so excited about it.

A perspective on Triall
Have you ever wondered what has been done to ensure that the medication you take has been thoroughly researched and tested?

Photo by Danilo Alvesd on Unsplash

More than 20,000 clinical research studies begin each year. For each new medicine, at least three clinical research studies are usually required to answer questions about its safety and how well it works. It often takes up to 10 years (and sometimes longer!) to collect all the information needed.*

In our modern fast-paced world you may wonder why you are limited to medication or treatment that was conceived of almost a decade ago.

The process of launching a new medicine
Evidence collected in clinical research studies is used to apply for legal approval for the use of new medicines.

Beyond legal approval of a new medicine, Government agencies, healthcare providers and pharmaceutical companies also work together to establish whether a medicine is good value for money. This may include learning more about how the medicine works in the ‘real world’ — i.e. outside the tightly controlled conditions of a clinical research study. This takes up to 66 weeks with a wide country to country disparity.*

Photo by National Cancer Institute on Unsplash

So it is not simple, it is not straightforward and yes it takes a long time. We are all affected by the cost, quality and pace of clinical research.

The three challenges

Cost
You may think ”why worry about cost if big pharma or governments/taxpayers will foot the bill?”. Firstly it needs to be understood that research into medicines constitutes a very large percentage of drug companies costs. Pharmaceutical companies spend, on average, over 25% of revenues on R&D, making it one of the biggest spenders in this area. Outside of the semiconductor industry, no other industry spends more on R&D. See https://www.drugdiscoverytrends.com/pharmas-top-20-rd-spenders-in-2020/

Photo by Fabian Blank on Unsplash

However the reality is if we can reduce research cost and hence the resources required, then the companies involved can afford to do more, which should result in wider research and potentially a faster pathway to new discoveries and medical progress.

Quality
This abstract is from an article titled Protect us from poor-quality medical research — notes from the ESHRE Capri workshop group, (an initiative, started in 1986, which annually brought together researchers from all over the world to discuss topics in the field of human reproduction.)

Much of the published medical research is apparently flawed, cannot be replicated and/or has limited or no utility. This article presents an overview of the current landscape of biomedical research, identifies problems associated with common study designs and considers potential solutions. Randomized clinical trials, observational studies, systematic reviews and meta-analyses are discussed in terms of their inherent limitations and potential ways of improving their conduct, analysis and reporting. The current emphasis on statistical significance needs to be replaced by sound design, transparency and willingness to share data with a clear commitment towards improving the quality and utility of clinical research.

Quality of research is understandably a serious issue. It is in all our interests to ensure that research conducted is done to the highest standards to ensure it can be relied upon, so anything that can help improve quality is incredibly important.

Pace
The rapid development of Covid vaccines illustrate what happens when everyone involved is properly motivated to participate constructively, the pace at which this was done was amazing!

With thanks to the British Society for Immunology

This was not only a pace we can go at when we genuinely try, but also a demonstration of the pace we need to begin to combat a rapidly spreading and mutating virus that has savaged both the human population and our economies.

The way to tackle the three challenges of cost, quality and pace is to address the underlying problems.

The underlying problems
The industry faces several persistent issues that make clinical trial operations overly complex, lengthy, and resource-inefficient.

  • Data is scattered across sites and systems.
  • Lack of oversight — Reported by virtually all clinical trial professionals
  • Record keeping failure — Causing significant delays, costs, and safety risks.
  • Data integrity issues — A growing concern according to authorities globally.
Photo by Emily Morter on Unsplash

Triall’s approach to the underlying problems
So what can we do about these problems for ourselves and future generations? Enabling a future of smarter, safer, and more-efficient clinical trials is vitally important- which is where Triall comes in. Bringing together a consortium of clinical operations experts, enterprise IT specialists, and blockchain developers, Triall is building the world’s first digital ecosystem for clinical trials.

Triall are enabling blockchain technology to become a tool to assure data integrity and clinical trial reliability. Once registered in the ledger, entries cannot be altered without notice, establishing an immutable audit trail of documents or other data entries and their evolution throughout the timeline of clinical development (it is ‘blockchain agnostic’, and it’s current APIs are integrated with the Factom Protocol, Bitcoin, Ethereum, and several other well-established blockchains). This should then make it possible to reduce costs and increase both the quality and pace of medical research.

Triall’s approach therefore has the potential to make hugely significant improvements!

Cube3 is therefore particularly excited about this project, primarily because it has the potential to significantly and positively impact everyone’s health through the improved management of clinical trials and quicker development of effective treatments. However we are also excited to see yet another strong project building on Factom. As a long-standing Authority Node Operator we continue to provide network services, alongside and with fellow stakeholders and it is great to see some of the key benefits of this protocol being recognized by new teams building in this space.

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The Factom Protocol

The Factom Protocol (initiated in 2014) is an open-source data integrity protocol which provides high-throughput and secure data entries at a low and stable fixed cost. It does this through efficiently organizing data, allowing data entries to be grouped into separate chains and thus making it easy to examine what data does and does not exist within a specific chain. It uses a data anchoring policy where ‘Merkle roots’ of the Factom blockchain are periodically registered on Bitcoin and Ethereum, taking advantage of the security levels of these major public blockchains. With a track-record of industrial and governmental applications it is optimized for enterprise adoption.

Cube3 Technologies Ltd

Cube3 Technologies Ltd is an independent and experienced UK operation running sophisticated blockchain infrastructure. It utilizes closely-monitored, enterprise-grade hardware in two high-availability datacentres and carefully designs its systems to provide multiple-layers of redundancy. It has been an Authority Node Operator for the Factom Blockchain since 2018. As a socially responsible organization, it donates a portion of its profits to medical research charities.

References

* “From clinical trial to available medicine — why does it take so long?” by Durhane Wong-Rieger https://www.patientresearchexchange.org/stories/detail/from-clinical-trial-to-available-medicine-why-does-it-take-so-long


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