We’re excited to introduce the new Triall Product Spotlight series on Medium. In this article series, we walk you through the different software products and features of our end-to-end eClinical platform, focusing on one core product category each week. This week, we zoom in on the features, benefits, and integration options of our electronic Patient-Reported Outcome (ePRO) solution.
Clinical trials are increasingly taking place outside of the clinic. These so-called ‘decentralised’ or ‘hybrid’ trials underline the need for tools that enable remote data collection and monitoring. Triall offers an electronic Patient-Reported Outcome (ePRO) solution that allows clinical trial participants to carry out surveys from any location using their own device, with little or no training. These surveys can for instance relate to study outcomes or the reporting of adverse events.
In this article, we’ll walk you through the main benefits of the Triall ePRO solutions as well as our current options for blockchain integrations and future vision for identity and access management.
Benefits for clinical research professionals
Clinical research professionals can quickly create and deploy device-specific Case Report Forms (CRFs) or surveys for web and app interfaces, to be filled out by patients during the study. The Triall ePRO application subsequently allows them to view and manage data as it comes in, where real-time updates support the monitoring and managing of data entries and results in a fast and comprehensive manner. As data is directly captured into the system, the application also reduces the chance of data integrity issues, such as data entry/transcription errors.
The Triall ePRO solutions furthermore helps safeguarding patient safety by providing researchers with real-time notifications regarding safety concerns (e.g., if nausea is reported more than twice a week). This enables site staff to take timely action without any unnecessary delays.
Benefits for clinical trial participants
Clinical trial participants (i.e., patients or healthy volunteers) are offered a simple tap user interface for data collection through simple multiple-choice or open-ended responses. The Triall ePRO solution promotes patient engagement throughout the study and eliminates missing data using automated notifications and reminders that promote survey completion via email and/or push notifications and icon badges that show which forms are still due.
Our ePRO solution is available on iOS, Android, and in-browser, meaning patients can interact with the application at any time and place using their own device — this is also referred to as ‘Bring-your-own-device’ (BYOD) in clinical research.
The Triall platform comprises a modular configuration of integrated clinical trial software (eClinical) applications for data capture, document management, planning & oversight, trial supply management, wearable integration, and more. The Triall ePRO solution is available as part of this end-to-end eClinical platform and can therefore also collect data from wearable and Bluetooth-enabled devices, where all ePRO and wearable data is directly stored and maintained within a secure cloud-based database. Alternatively, the Triall ePRO solution can be offered as a stand-alone tool for clinical trials running outside of the Triall ecosystem.
Triall’s Verifiable Proof API
The Triall ePRO solution can easily be integrated with blockchain through our Verifiable Proof API. By using our API, researchers can timestamp their patient-level data on the blockchain, right at the moment where it is generated. These blockchain timestamps provide verifiable proof that data was present at a certain point in time and has not been altered since. They therefore mitigate the corruption or manipulation of data at a later stage and improve the reliability of clinical science and good clinical practice (more info on verifiable proofs).
Creating verifiable proofs over the course of a study generates an immutable and verifiable audit trail that (1) lives independent of the systems used to collect data and (2) is kept available by a distributed network of computer servers (‘nodes’) who are incentivised to maintain the blockchain network. This means that long after a trial is concluded and applied eClinical systems have been retired, auditors and regulators can still verify the validity of the trial results.
Triall is building a Self-Sovereign Identity (SSI) infrastructure that allows us to decentralise identity and access management (read how we are applying this in informed consent). This infrastructure will provide participants, researchers, and other platform users with greater ownership and control over their data, documents, and processes. In the context of ePRO, participants would be able to securely store and monetise their survey data for future research purposes, where ownership rights are distributed between both sponsor and participant. This would open up the possibility for new (tokenised) business models where TRL can function as a common currency.
Triall brings Web3 to medical research by creating a digital ecosystem of blockchain-integrated software solutions that secure and streamline clinical trials. Triall’s solutions make clinical trials tamper-resistant and enable secure and efficient integrations between the many isolated systems and parties involved in clinical trial processes. Triall’s software is co-created with clinical trial professionals to ensure optimal user experience, solving actual industry pain points.
Visit the website: https://www.triall.io