What does it take to be a modern eCOA/ePRO platform?
By Julia Lakeland
Chief Product Officer
eCOA/ePRO solutions were introduced about 15 years ago, and many mature systems still use a version of the legacy technology originally used to develop them. As a result, some eCOA/ePRO systems may be out of date with today’s cloud computing and coding technologies and have a rigid backbone with inflexible custom integrations into other legacy clinical systems. These constraints can make them inflexible in how they perform and respond to capturing digital clinical data from the patient and present challenges for users at clinical sites. They also affect eCOA/ePRO systems’ ability to respond to modern research questionnaires that require images and other digital solutions, such as file uploads.
Seeking an alternative to outdated technology, some newer vendors develop and deploy an individual app for each study. This approach is neither scalable nor sustainable for future R&D. It is also costly for customers to use and manage.
Both solutions fall short in their ability to truly embrace how technology can be used to meet individual patient and site needs, maximize engagement, and bring about high compliance, especially in real-world studies.
Today, sponsors are looking for modern and reliable eCOA/ePRO systems, designed to support increasingly complex, individualized, and remote or hybrid clinical trials and real-world research initiatives.
From my experience, there are several key characteristics that define a modern eCOA/ePRO system:
Modern eCOA/ePRO is patient-centric
Patient centricity should be the bedrock of modern eCOA/ePRO systems and the key to delivering a superior patient experience. They must first, foremost, and continually filter study and data requirements through the human-experience lens of the user—whether that user is a trial participant, caregiver, or a clinical trial investigator working at a site. The importance of patient centricity cannot be understated, and we will focus exclusively on this foundational characteristic in our next blog.
Modern eCOA/ePRO is designed for configurability and extreme scalability
Time to study launch is more important than ever for trial sponsors and contract research organizations (CROs). As mentioned above, some vendors develop bespoke apps for each study, a time-consuming process that slows time to market and increases costs. Modern eCOA/ePRO delivers extreme configurability that supports rapid scale without tradeoffs.
eCOA/ePRO solutions often claim to be highly configurable, meaning they can capture different instruments according to a study protocol. Having a library of readily available clinical outcome assessments that are quick to deploy is a given expectation across the industry. Modern configurability, however, extends well beyond this capability. It actually gives trial sponsors the ability to optimize the overall user experience through highly tailored design and presentation of functionality, study information, and questionnaires.
Industry professionals understand that protocols often change while a study is in flight. Therefore, clinical systems, including eCOA/ePRO, must adapt readily to study design changes. The ability to publish new study information throughout the duration of the study to both sites and participants is a requirement for certain protocol design changes. In addition, the ability to present educational content to the patient throughout the study gives them a greater sense of participation, ownership, and empowerment—supporting greater patient engagement. Surfacing well-formatted study information through mobile apps also reduces the burden on the site to perform frequent outreach initiatives.
Modern eCOA/ePRO can meet the unique needs of all research phases
Clinical phase 2 and phase 3 studies typically have high compliance because the sites are highly involved in driving protocol adherence. In real-world/late-phase studies with long duration, sponsors need modern tools to support and ensure engagement in the absence of the frequent in-person interaction that physical clinical sites afford. The intuitiveness of modern eCOA/ePRO solutions and their ability to deliver real-time, dynamic support encourages strong and sustained patient engagement in real-world studies.
Modern eCOA/ePRO is powered by the latest technology
Combining APIs with a modern micro service, cloud-based technology stack creates solutions that are highly scalable, configurable and efficient. They remove the complexity associated with deeply linked data integrations and grant access to extensive code libraries, which enable rapid development of new features and platform enhancements. To meet the demands of the increasingly complex protocol submission process, sponsors today must combine data from multiple fragmented systems, including interactive response technology (IRT), electronic data capture (EDC), clinical trial management systems (CTMS), eCOA/ePRO, wearables and real-world data lake systems. Publicly exposed and secure APIs support scalability (as well as agility) by creating a framework of reusable APIs that makes it easy to extract and present data for analysis.
Modern eCOA/ePRO is feature-rich
eCOA/ePRO system designs are typically linear and reflect the fact that the majority of questionnaires are transcribed from paper to electronic format. Depending on its complexity, simply rendering a paper-based questionnaire in an electronic format does not necessarily make it “easy to use,” The increasingly complex questionnaires associated with modern studies can be difficult for some eCOA/ePRO systems to present.
Modern eCOA/ePRO, in contrast, provides a feature rich, mobile-device-agnostic experience that supports Bring Your Own Device (BYOD) via a harmonized, single app solution. It delivers responsive layout for mobile devices to ensure that content is presented effectively across all modalities and all study stakeholders are well informed.
Further, modern eCOA/ePRO has the ability to render exit actions combined with dynamic (versus static) reminders that improve the patient experience and maximize data capture and compliance. Increasingly, there is also a need to deliver robust image upload functionality that enhances the ability to capture and analyze new measurements alongside eCOA/ePRO responses. This capability can be particularly effective when combined with medical analysis for therapeutic areas including oncology, dermatology, and vaccine studies.
Finally, modern eCOA/ePRO includes robust data reporting and study analytics that deliver real-time data for sites, sponsors, and monitors.
Modern eCOA/ePRO drives innovation
Driving innovation is key to successfully improving how we conduct scientific research. The benefits associated with adopting a patient-centric study design and taking the trial to the patient are widely understood. Modern eCOA/ePRO goes beyond simply putting a mobile device in the hands of the patient. It must improve the overall experience of the patient, beyond that of being able to complete questionnaires and speak with a doctor remotely.
The Motif graphical user interface, patented by uMotif, plays a vital role in eCOA/ePRO-driven innovation. It is the first validated innovation in ePRO since paper forms were put on the smartphone. The Motif is a patented, flower-like graphical user interface. Each petal represents a different question, such as an Outcome Measure, symptom, or eDiary entry. Patients simply swipe on each petal to capture their data. The highly visual and easy-to-use interface is faster and more engaging for patients, which leads to higher rates of data capture compliance.
Clinical trial designs continue to advance in complexity due to the growing need to get drugs to market quickly and differentiate medicinal products. Increasingly patients with certain chronic diseases will select the clinical study that best meets their needs and supports their care plan of choice. Modern eCOA/ePRO systems, that are reliable, scalable, configurable, feature rich and easy to use, can support study enrollment goals, foster high patient engagement long term, and accelerate time to data lock.
Explore how uMotif’s validated eCOA/ePRO platform can help you achieve your research goals.