Complex as they are, clinical trials often involve many different organizations, locations, and data sources. This makes virtually all stakeholders having trouble to keep track of their documents and data.
Yet, regulations are getting even more tight, demanding meticulous documentation from all trial conductors. What’s more, all trial interventions could be auditable at any time!
As it seems, the future holds new challenges for document management in clinical trials, especially in terms of transparency and traceability.
The current situation is that centralized systems – used as data management platforms in clinical trials – usually do not provide trustable traceability logs. This is because they are controlled by a single stakeholder that provides management services.
The lack of oversight on all levels hampers record keeping, resulting in costly reiterations, errors, and even safety risks for patients and consumers. Furthermore, the lack of complete traceability makes the data susceptible to corruption by errors or misconduct.
In recent years, a solution to these issues has emerged within the concept of Blockchain technology.
It is presumed that Blockchain can provide all stakeholders with indisputable proof that data has been recorded at a set time, under a verifiable condition.
Key Features of Blockchain
Blockchain is a technology used in the cryptocurrency transactions that is famous for its built-in data incorruptibility. It ensures confidence between different parties and back legitimacy through the whole process.
Technically, it is a secure and transparently distributed datastore or ledger of ordered records of transactions.
Network participants, such as cryptocurrency traders, receive an unaltered copy of the datastore and can validate the transactions by a safe cryptographic process. This way, trust in transactions is validated and streamlined throughout the network.
All stakeholders – even the ones that distrust each other – can interact by using the same temper-proof dataset, without the need for third-party interventions.
Blockchain Benefits for Clinical Trials
In comparison to existing system, Blockchain may help track more closely the series of events occurring in clinical trials.
The Blockchain-like architecture of a data management system in clinical trials could provide transparency control for all participants.
The key technical features that aid clinical work are:
- Smart-contracting, and
- Blockchain storage.
The time-stamping of data alterations accounts for secure, consistent, and incorruptible proof-of-data storage. Moreover, it provides transparency in data entering and allows validation on all levels.
Time-ordering installs a predefined trial timeline, thus assuring for event consistency and integrity of all time-ordered events.
Smart Contracts are predefined quality work streams, which are executed by conditional computer functions embedded in every decision process. In other words, computer scripts are executing contractual clauses on which co-contracting parties agree.
Furthermore, clinical trial work streams could benefit from secure, unalterable storage on the Blockchain cloud, which can be remotely audited, with an appropriate time-stamp. Additionally, critical resources, such as metadata of a clinical trial, could be attached to the cloud and, if needed, be provided to regulatory authorities.
Blockchain could also be used to store proofs of consent that has been signed by a major stakeholder, ranging from informed patient consent to eCRF validation.
The use of Blockchain-powered repositories of clinical trials with a standardized format could be used for data archiving and be accessible via a dedicated search engine. This way, data analysis can be outsourced to a third-party and processed remotely, without breaching data privacy.
If applied, Blockchain could prevent fabrications of informed consent forms, ward-off data dredging, and install database locks.
1. Informed Consent Form (ICF) Authenticity Assurance
Patients should only be enrolled in a clinical trial after having provided their full, informed consent on the study design and procedures.
By registering a hash of the signed ICF on the Blockchain, researchers can prove that the patient has consented to participate in the clinical trial in a timely, unfalsifiable, and verifiable way.
Moreover, Electronic Data Capture (EDC) tools may also be integrated with the blockchain layer, thus only allowing data inputs for a specific patient after that patient’s ICF has been registered on the Blockchain.
In case there has been a change to the study design, data inputs could be allowed only after patients have consented to the protocol alterations.
2. Predefined Outcome Measures
By registering a hash of the Statistical Analysis Plan on the Blockchain before the start of the trial, researchers can prove that they have adhered to the predefined outcome measures.
This way, the dangerous malpractice of changing the initial clinical trial hypothesis and analysis plan after analyzing their research data (p-hacking or data dredging), is prevented.
3. Database Lock
By using Blockchain technology, researchers can generate verifiable proof that their data set has not been altered. This way, the Blockchain technological solutions can prevent evidence alterations, such as unintentional and unauthorized changes after final data entry, check-up, and analysis.
Similar Tendencies in MDR
Preservation of data integrity is becoming the new imperative, even beyond clinical trials. Namely, the European Commission is developing a new EUDAMED platform to replace the existing web-based portal used for the regulation of medical devices.
The new EUDAMED will be multi-purposed, contain a much more extensive database, and is intended to be used as a collaborative system, a notification system, a dissemination system (open to the public), and will be interoperable.
From an IT perspective, new EUDAMED will need to have a machine-to-machine data transfer capabilities, that are incorruptible, and, preferably, have a time-stamp on it. The project is still at the development phase, and the authorities have not officiated that they will use the Blockchain technology. However, it is clear that the need for data integrity and transparency urges such tendencies.