Contributing to therapeutic drug development using Amazon Managed Blockchain

In the pharmaceutical industry, the cost of clinical research and clinical trials is extremely high, which results in higher drug prices and insurance expenses. Furthermore, the high costs have resulted in decreased numbers of clinical trials at national research institutes and universities, slowing the progress of pharmaceutical research. In addition, incidents of data falsification or misrepresentation in academic papers and clinical research has resulted in stricter management controls, which has also contributed to increasing the cost of clinical research and trials.

In response to these challenges, the healthcare industry expanded its use of blockchain for its tamper resistance and transparency characteristics. The novel coronavirus infection further expanded the use of blockchain for drug distribution, counterfeit product countermeasures, and data utilization in clinical trials.

Susmed Co., Ltd. (Susmed), a research and development company promoting digital medicine, primarily develops smartphone applications for medical / therapeutic purposes and provides clinical trial systems using blockchain technology. Susmed announced that it has entered into an agreement with Aculys Pharma Co., Ltd. (Aculys Pharma), which promotes the development and commercialization of innovative therapeutic agents in the field of neurological and mental disorders, to build the world’s first corporate clinical trial solution on blockchain. In addition, Susmed announced the start of Aculys Pharma’s domestic phase 3 clinical trial of Pitolisant using blockchain technology for clinical trial management.

By utilizing Amazon Managed Blockchain in this system, Susmed is contributing to the realization of clinical trial efficiency using blockchain technology to support drug development.

Under the Cabinet Office’s sandbox program, Susmed has conducted a demonstration of a clinical data monitoring system using blockchain technology. Tomomitsu Motohashi, CTO of Susmed, explained the blockchain architecture centered on Managed Blockchain and the need for blockchain for services as follows:

• Blockchain technology makes it difficult to tamper with data, which helps to monitor clinical trials and certain clinical research.
• Blockchain improves the level of security compared to the conventional method while enabling cost-effective and accurate monitoring. This reduces R&D costs and contributing to maintaining and enhancing the international competitiveness of the Japanese pharmaceutical industry and the sustainability of social security.

This demonstration was conducted in collaboration with the National Cancer Center of Japan and was monitored in a clinical trial for the development of an exercise program to promote behavior change in cancer survivors who have no exercise habits.

The reliability of the data was consistently ensured by recording the transmitted data directly on the blockchain. This makes it difficult to falsify the stored data by using technologies to prevent vulnerabilities in the client and relay servers, including the use of specialized applications for data entry (no transcription from the source data to the report data). As a result, the reliability of the data is verifiable even if the monitors don’t visit the site and check the source documents against the reportable data.

The Minister of Health, Labor, and Welfare and the Minister of Economy, Trade, and Industry have since announced in writing that blockchain technology is legally allowed to replace the monitoring required in clinical trials of pharmaceuticals and medical devices.

Susmed has also patented this method, and we believe that this is a new and valuable application of blockchain technology. The Susmed AWS principles are as follows:

• Use fully managed services as much as possible to reduce operational costs by using a serverless configuration
• Utilize AWS CodeBuild for continuous integration
• Because of the high degree of reliability AWS services offer, use AWS services unless there is a major reason to do otherwise

Based on this policy, we initially built a Hyperledger Fabric environment on an Amazon Elastic Compute Cloud (Amazon EC2) instance, but later migrated to Amazon Managed Blockchain, a fully managed service. In this post, we explain why we decided to use blockchain and share some key points about our blockchain-based architecture.

The choice to use blockchain technology

In clinical research and trials, there are audits with multiple stakeholders, which can take an enormous amount of time and money. Depending on the nature of the trial, the cost can be greater than hundreds of millions (yen) and 20–50% of these costs are outsourced to CROs (Contract Research Organizations) or SMOs (Clinical Trial Facilities Support Organizations).

The following figure illustrates the parties involved in clinical research and clinical trials and their respective relationships (taken from the Japan SMO Association).

If there is falsification of testing or research results, not only would the enormous amount of time and money spent on auditing and testing be wasted, but also drugs would not be properly evaluated, making it impossible to provide appropriate medical care to healthcare professionals and patients.

Today, majority of data is confirmed by observers and other human operators to achieve high tamper resistance, which is a major reason for blockchain technology gaining traction.

Blockchain is positioned as just one of the security layers. The goal is not to achieve decentralization, but to shift the IT authority structure from a hierarchical structure to a parallel structure.

As for blockchain networks, they can be broadly classified into three types:

• Public – A blockchain that can be used and viewed by anyone
• Private – A blockchain in which a specific person or company is the sole administrator and only authorized users can view and use the transaction information written to the private chain
• Consortium – Multiple authorized organizations or companies collectively have control and can reach consensus on transaction information among participants

For clinical research and clinical trials, we decided to use a consortium type blockchain, which can identify the participants who can join the blockchain and use majority voting, for the following reasons:

• It doesn’t generate large amounts of data and doesn’t impose strict throughput requirements
• There’s no need to distribute data to an indeterminate number of people for sharing and verification

Database compared to blockchain

Databases can also be considered as an option for tamper-proof purposes. However, it is difficult to prove that no one has tampered with data after it is stored in a database or shared with multiple companies using only database technology.

A database, unlike a blockchain, is a centralized ledger operated by an administrator. Since the database has a user with administrator privileges, it is easy to tamper with data without leaving any evidence. Therefore, there is no transparency. In the case of a database, data may be exposed depending on the authority settings of the administrator, but it is difficult for users of the database to verify the integrity of that data. A key property of blockchain is that anyone with the right tools can verify the data written to it. In this respect as well, clinical trials using blockchain technology are pioneering efforts to solve medical problems.

The importance of using blockchain has been detailed in a report published by the National Institute of Standards and Technology (NIST) and in a whitepaper entitled “Do you need a blockchain?” (CVCBT, 2018). The following diagram from the whitepaper shows that if the stakeholders are trustworthy (no incentive to tamper), a regular database is sufficient, but in other cases, a blockchain is worth using.

Solution overview

For the overall architecture, refer to the following presentation from AWS Dev Day in October 2020. AWS Dev Day is one of the largest conferences in Japan held by AWS for development engineers.

In the following diagram, we describe the architecture up to the point of writing data to the blockchain.

Let’s discuss the three main design principles behind this architecture.

Blockchain should be combined with components as needed

As mentioned earlier, blockchain has the advantage of being highly tamper-resistant. However, care must be taken with the configuration. A blockchain alone can’t meet all requirements. Depending on the chain used, it may not be compatible with workloads that require high throughput or complex transactions. (For more information, refer to the blockchain trilemma) Therefore, when building a blockchain service, it’s necessary to combine components according to requirements.

Reduce operational burden with a serverless configuration

We used fully managed services as much as possible. We also adopted a serverless architecture to reduce operational costs. All infrastructure configurations are managed using an automated configuration tool (Terraform), so that deploying the same environment doesn’t require a large amount of time. With no operational burden and automation in place, we are able to develop and operate three services with seven engineers and one designer, and put an efficient development system in place.

Ready to use, ready to destroy

Especially in the clinical trial system, it’s always decided that the trial will be completed within a certain period of time. Therefore, cloud computing and Susmed’s services are very compatible because they can be used when needed and resources can be removed when not needed. In addition, in blockchain, it takes a lot of effort to create and delete resources, but in Managed Blockchain, you can create and delete the entire blockchain resource itself, which makes it easy and flexible to scrap and build without any hassle.

Conclusion

In this post, we discussed how Susmed is looking to solve the high costs and inefficiencies of clinical trials, and the resulting increased social security costs and research delays, by using a new digital technology—blockchain. AWS offers a wide range of more than 200 cloud services, including Managed Blockchain, and has been firmly committed to continuous innovation and investment in Japan since 2011. AWS is committed to contributing to society by transforming businesses and solving national challenges through cloud computing, and we will continue to support healthcare DX in the cloud and further accelerate DX in Japan together with Susmed, Aculys Pharma, and many others who are taking progressive steps to solve problems in the healthcare industry. We will continue to accelerate DX in Japan as a whole.

This post was translated from the AWS Japanese Blog, link to original post. To learn more about Amazon Managed Blockchain and other customer success stories, explore our catalog of blog posts.

About the authors

Tomomitsu Motohashi is Chief Technology Officer at Susmed.

Kimihiro Tohyama is a Business Developer Manager at AWS Japan.

Yuki Nakatake is a Solution Architect at AWS Japan.