In part one of our exploration of the three ‘Ds’ of DCTs, we tapped into the clinical research industry’s rising interest in, and confusion around, a standard definition for DCT.
We explored the differences between what people commonly take the ‘D’ to stand for, i.e., decentralized, distributed, or digitized trials. And we highlighted the importance of getting clear on the definition as you begin to develop your strategy.
The critical point to remember is that digitization, distribution, and decentralization are not mutually exclusive. Depending on the strategy, a clinical trial may include all, some, or none of these approaches in an effort to streamline clinical research timelines, costs, and effectiveness.
In part two, we now focus on the blockchain’s potential to facilitate DCTs. We include examples of how blockchain can be used for clinical trials and examples of digitized, distributed, and decentralized tasks.
Whether decentralized, distributed, or digitized, data is at the heart of DCT. Blockchain lends itself well to peer-to-peer networks that enable decentralized control and decision-making. In a digitally connected world, distributed clinical trial tasks make a lot of sense for improved outcomes, greater inclusion, cost savings, patient convenience to improve retention, efficiency, and more.
Blockchain-based solutions can have an impactful role in DCT. For example, many blockchain-based solutions today are based on following an asset, represented by a coin or token, as it moves through a series of wallets. This model lends itself well to chain of custody use cases like traceability of an investigational drug or device in a clinical trial.
It is important to recognize that in many existing token-based blockchain platforms, the actual data or asset is not captured in blockchain, just the coin or token. Also, be aware that some blockchain engines are not natively encrypted. Any healthcare implementation should address security holistically and be designed-in, rather than designed as an afterthought (e.g., just transferring data over SSL is all I need for security). SSL stands for Secure Sockets Layer and is the “s” you see in “HTTPS” in web addresses. While important, SSL alone is usually not enough when protecting data in terms of access, privacy, and security.
When blockchain is used as encryption technology and advanced for distributed/decentralized data management, the data itself is secured in blockchain. At emTRUTH, for example, we are blockchaining the data because data is the asset, not a coin.
Using a token-based platform for drug or device traceability is an example of a decentralized clinical trial task. It is decentralized because the transfer of ownership, custody, or location is typically executed automatically when a set of pre-defined criteria, often captured in a smart contract, is met. A smart contract is just a block of code that expresses what criteria must be met before initiating a transaction.
Sharing the right data, with the right people, at the right time
Clinical trials involve many participants doing many different things at many different times. Anonymized patient demographics shared with pharma as potential trial candidates is different from tracking test results or biometrics for an individual patient during the trial itself.
Blockchain for DCT must support the full spectrum of data access, as that is what healthcare and DCT require – from transactions that are completely anonymous (i.e., we do not know who is creating the data blocks) with data publicly accessible by anyone like in cryptocurrency application.
Some examples of where healthcare data might publicly be accessible include an efficacy summary of a new drug, the demographic distribution of trial candidates, etc. Even for publicly available data, it is important in healthcare to know where this data came from (i.e., not anonymous). Examples of highly confidential data with access restricted to only a named few include trade secrets, patient data, pharma intellectual property, etc. Access, like data, should be purpose-driven and not one size fits all.
Managing, controlling, and monitoring data access with a system or application is an example of digitized clinical trial tasks and with emTRUTH, also distributed, because people own and control their own data (e.g., sharing of anonymized patient profiles with pharma, pharma sharing trial data with FDA, and sharing test results with a patient’s primary care provider.)
Purpose-driven access is contextual. For example, data that a drug distribution warehouse sees as part of the supply chain for tracing and accountability of a drug being tested, is different from the data your primary care provider sees about your clinical trial participation and any potential impact to your health.
Beyond an eForm for Informed Consent
Using an electronic patient consent form is one example of a digitized clinical trial task. emTRUTH helps trial sponsors and research organizations move beyond electronic versions of consent forms. Instead, it is possible to immutably capture each consent to the actual specific dataset itself. This creates a better approach to managing disparate and heterogeneous data from many places, as the consent dataset always includes what data is captured, who can access this data, and how this data can be used. Because consent is now attached immutably to the data itself, data governance about sharing and usage is at the forefront and transparent for all stakeholders.
For example, anonymous demographic data and pre-screening with MRI images linked to consent can be part of a dataset for patients considered for a clinical trial. Patients can rescind consent at any time. When they do, the data is no longer shared. When patients are empowered, it is more likely that we will improve trial candidate diversity, and more accurately reflect the patient population. Patient empowerment also impacts higher trial retention. Through patient empowerment and clarity of consent, clinical trials can promote trust in the process and trust in the data.
Data Protection, Privacy, and Ownership
Data should be secure, protected, and in regulatory compliance, especially clinical trial data. Because clinical trials involve many different people and organizations doing different things, a thoughtful process is needed about sharing the right data, with the right people, at the right time. This means we need a clear understanding of data protection and privacy requirements for these various trial tasks.
As more data is digitized, organizations, like pharma and government agencies, want to make better use of this data, i.e., reuse data from one trial for other clinical research. This translates to a need for easily combining different data into different datasets with different levels of access and granularity based on purpose. All while being mindful of data protection, privacy, and the right to use this data for a new purpose. That purpose being a specific objective in a clinical trial (e.g., select trial candidates, sharing test results with clinicians for review and analysis, compiling data for FDA approval, or tracking a trial drug or device).
We believe that data should be purpose-driven, because the kind of data you need and how it is consumed, is different for a dashboard of trends versus a training set for machine learning and AI.
Blockchain lends itself well to maintaining data ownership and control. At emTRUTH, for example, we create blockchains under their respective owners, like how domain names are registered to their owners. People own and control their own data. emTRUTH simplifies the mechanics of making data work together. What data is shared, and who has access, is up to the data owner, following their own data governance criteria and policies. Once mechanics are simplified, then something meaningful can be done with the data (e.g., analysis, analytics, training, and more).
Smart contracts is another emerging digital capability to enable DCT. Cryptocurrencies use smart contracts to govern coin exchange between wallets. Historically, many cryptocurrency mishaps and exploits happened because of poorly written or tested smart contracts.
Particularly for clinical trials, where data is highly sensitive and confidential, smart contracts should be developed and tested as mission-critical software. Smart contracts today are better suited for pro forma, perfunctory, and well-understood procedures. Some of the higher-level abstractions (e.g., data governance compliance, legal transfer of ownership, etc.) are still nascent. We need smarter contracts before more complex data autonomy is ready for wide operational use in DCT.
Technology, provided by companies like emTRUTH, exists for greater data autonomy. For example, sharing anonymized demographic and comorbidities data with pharma as a potential clinical trial candidate only if a list of criteria has been met (e.g., patient consent for this anonymized data sharing, which pharma companies, care providers, or individuals to share this data with, expiration on this informed consent following best data governance practice; required next steps; etc.)
What is missing is a broader conversation and thoughtful process around the implications and unintended consequences of data autonomy through technologies like smart contracts. Ideally, defined data governance that includes a set of criteria and policies should already be in place before embarking on decentralized data autonomy in clinical trials.
Even better, best practice data governance should be an accepted industry standard and part of a patient’s bill of rights.
The future of blockchain in DCT
There is so much untapped potential for blockchain in DCT that can improve outcomes, lower the cost of bringing new drugs or devices to market, empower patients for more inclusive trials and build trust in the data and trust in the process.
Is blockchain a part of your DCT plans? Do you have a roadmap that defines how you get from where you are today to where you want to be? We would love to hear your thoughts and plans.
About the Authors
Irene Woerner is CEO and Co-Founder of emTRUTH. Irene and Ron Kong (CTO and Co-Founder) chose to focus their foundational technologies in healthcare because of the meaningful impact they can have in improving outcomes while managing costs.
Aman Khera, Global Head of Regulatory Strategy at Worldwide Clinical Trials, has been providing global strategic direction in regulatory affairs for more than two decades. She has built her career on maintaining fastidious patient care with the pragmatism needed to help clients achieve effective regulatory strategies. Aman is available to consult with companies of all sizes, as well as their funding entities, to support their goals – with the primary aim of serving humanity as a whole.
emTRUTH® unlocks the power of healthcare data. We do this by making it quick and easy for healthcare users (who are not IT experts) to securely combine and share data on demand while they, and their patients, retain full ownership and control of their data. The company's patented technology offers fast and secure horizontal or vertical data integration and interoperability of any type of data. With one API. From anywhere. Using any standard. To any app. In days, not months. For less. For more information, visit www.emtruth.com.