In recent years, conducting a successful clinical trial, which requires collecting huge amounts of data, could easily be advanced with the help of AI, machine learning, algorithms and IoT. At the same time, elevated standards for data safety, privacy enforcement, and transparency increase the complexity of the work and the overall study costs.
Based on Innovative Technology Developed in Iasi
When we started collaborating on the PharmaLedger project, this was one of the first technical dilemmas that we were confronted with: how can we create an app that could help streamline the complexity of modern clinical trials, and at the same time ensure easy patient collaboration and data safety?
Our researchers started looking at some of the most innovative technologies available, analyzing their benefits as well as their limitations.
In this context, they came to the conclusion that blockchain technology could be used to a certain extent, as it offered the possibility to lay a foundation of trust and transparency at the base of this system that was set to involve multiple actors from the most diverse areas and with very different leverages of power.
At the same time, blockchain did present some limitations with implementing the principle of the right to be forgotten principle, with access rights, and overall system scalability.
That led to the decision to develop a new protocol, called Open DSU, where DSU stands for Data Sharing Unit.
A DSU is located off-chain and may have some data processing capabilities of its own (in this case it is called a self-sovereign app). The importance of having data stored off-chain is crucial from a data-security point of view. Data stored in DSUs is encrypted and only then directly anchored in the blockchains. From a technical point of view, this is the foundation on which the eConsent Clinical Trial app was built.
Four Main Actors
The eConsent Clinical Trial app includes the participation of four actors: Sponsor, Clinical Site, Patient and Researcher.
- Sponsor – The Sponsor is the entity that initiates and finances the clinical trial.
- Clinic – The Clinic is the actual clinical site or hospital where the study is conducted, and where the patients need to check in for the various treatments and procedures that are included in the study.
- Patient – The Patient is the trial participant, a person who has agreed to participate in the study in accordance with the terms of agreement that are signed through a number of mandatory and optional consent documents.
- Researcher – The Researcher is the actor who can make use of the anonymized data obtained in the trial, in order to interpret them and draw conclusions.
All these actors are assigned their own data wallets created on a blockchain infrastructure, that are uniquely identified through a decentralized ID (DID).
How Wallets Work
In order to ensure transparency and decentralization, each participant will access the eConsent application through their own private wallet. Patient data is only anchored to the blockchain, in order to ensure data privacy requirements. Every wallet is created with unique credentials.
Sponsor Wallet
The sponsor is the initiator of the clinical study and is responsible for creating the consent files and for the overall trial management.
Consents: Sponsors establish the rules and are not required to sign consents. They create the consent files, which are managed through the eConsent mobile app.
The sponsor is responsible for coordinating with the clinical site to ensure that consents and documentation comply with local regulations, tailoring the process to each country where the clinical trial is conducted.
Each consent file outlines the required visits and procedures for patients. Consents can be edited and re-signed if changes occur, with all changes tracked in the Consent History.
In Trial Management, the Sponsor is responsible for adding Clinical Sites and assigning trials to each one. They also establish a template for the clinical trial visits. Both the Sponsor and the Clinical Site have access to all the collected data, which is anonymized. The application can generate statistics and visuals, and it can be further personalized to meet various requirements.
Clinic Wallet
Enrolling Patients: The clinical site can recruit and enroll patients for the clinical trial. Eligible patients receive consent documents that they need to agree to.
Once the consents are signed, the clinic verifies the eligibility conditions. The doctor signs their own consent, completing the enrollment process. After a patient is enrolled in the trial, the Clinical Site assigns a TS (Trial Subject) number to anonymize the patient’s data.
Scheduling: At the Clinical Site level, the doctor will schedule Patient visits to the clinic for various procedures and treatments (investigations, placement of devices, treatment procedures etc.), in accordance with the visits template provided by the Sponsor.
Devices: Depending on the trial, certain IoT devices may be required to collect data that is relevant to the study context. This data needs to be retrieved and attached to that patient file.
Questionnaires: Every day, the patient must answer some questionnaires: one is related to the devices used in the trial and the other one is related to the patient’s general state. The answers can be set as free text, slider or checkbox.
Patient Wallet
The Patient Wallet is a smartphone app designed to streamline the consent process for clinical studies. The Sponsor uploads the consent documents and sends them to the Clinical Site. Patients receive these documents and can choose to sign or decline them. Even after signing, patients can revoke their consent at any time using the Withdraw option.
TS Number Once a patient signs the consent, the Clinical Site assigns them a TS (trial subject) number to ensure data anonymization. All study tracking is done using this TS number. Only the doctor at the Clinical Site can verify the identity associated with the TS number, maintaining the connection between the patient and their anonymized data.
Permissions Patients have full control over their participation and data. They can withdraw from the study at any time, and revoking consent makes their data inaccessible for further use. Patients can also decide whether to allow their anonymized data to be used for further research. If they agree, they will receive invitations from other researchers and can choose whether to accept or decline each request.
Researcher Wallet
Throughout the trial, a collection of patient data is obtained. This data can be opened for further research (comparative, preventive, etc.)
The clinical site can introduce new researchers.
A Patient Centered Approach to Clinical Trials
The eConsent app was built in a trust environment enabled through the PharmaLedger platform, based on transparency and decentralization. This environment is patient-centered by design – meaning that data is only used to improve diagnosis, prevention and personalized treatments, and the patient is the sovereign owner of their own data.
The main patient rights that are at the center of the eConsent app are: data ownership, data access, transparency of who, where and how data is used, the right to revoke data access at any time and the right to be forgotten.