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Integrated platforms enabling robust connection between patient technology, the site interface, and sponsor systems would streamline processes, reduce human error, and ensure real-time data is available within the appropriate systems.
FREMONT, CA: Improving patient experience has been debated for several years but needs more efforts to curb the low patient engagement and retention challenges across the clinical trial industry. Engagement and retention issues are primarily due to the industry's applying different patient engagement approaches. A patient participating in a trial requires to receive notifications, use an electronic patient-reported outcomes (ePRO) diary, and complete questionnaires from multiple applications while also using wearables or electronic concierge services.
Adopting numerous tools to engage patients and capture information also impacts sponsors and sites that need to learn and use various systems to execute processes. This method limits the opportunity to share common learning, develop standard procedures, or gain economies of scale through replication across studies. In addition, increased trial costs and complexity hinder a high-quality patient experience.
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The pandemic accelerated the shift to digital clinical research and rushed the adoption of remote patients. Digital tools became essential, and companies decentralised study processes. However, it has not been a harmonious path to mainstream acceptance. The industry is maturing, but there is still more work before patient engagement solutions are a core trial design and delivery component.
Disconnected technologies’ use cases drive concerns around the interoperability gap across clinical systems. Sponsors and CROs often believe the rapid adoption of stand-alone solutions for decentralised trials has led to inefficient internal workflows and challenges with collaboration and getting information in and out of systems. Clinical trials with disjointed systems result in added time, cost, and quality issues. For example, ePRO is a significant component of patient-centric trials but is often fraught with high costs and complex use protocols. The lack of consistency across trials further complicates ePRO’s configuration, testing, and rollout.
While using a stand-alone ePRO application for patient-reported outcomes, sites must manually enter metadata such as patient ID, visit schedule, study phase, etc. This process can be error-prone, requiring additional data management resources to validate the information. Patient data should be shifted from the ePRO database to another system before achieving a meaningful, holistic review. This end-of-study work is a pain point and a stark example of the ramifications of disjointed approaches to clinical trials following strict procedures to protect data integrity and security.
Practically, end-of-study media is often shared via password-protected USB thumb drives or CD-ROMs. Due to the lack of CD-ROM drives in modern laptops, ePRO vendors must provide external hard drives to the sponsor. This service requires study teams to jump through hoops to access the information and comply with security and privacy policies.
Despite ePRO generating more complex data than other solutions like eConsent or messaging, the same principles apply. As a result, study teams are unwilling to add new technologies to their trials. An integrated platform enabling an end-to-end connection between patient technology, the site interface, and sponsor systems would streamline processes, minimise human error, and ensure real-time data is available within the right systems.
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