Electronic Patient-Reported Outcomes (ePROs) have been a crucial development in clinical research in the last decade. Taking multiple forms – screen-based, SMS-based, even telephone-based – the abstraction of patient-reported outcomes and surveys to non-paper-based mediums has changed the number of patients researchers can reach, and the ways in which their data can be captured. While ePROs are by no means ubiquitous today, they are certainly common, with most clinical trial companies offering some form of electronic patient data capture as part of their offering, and with some vendors wholly devoted to ePRO creation.
The lines defining what an ePRO is, however, have certainly blurred in recent years - particularly with more studies being conducted in remote or hybrid environments. From what medium is used to collect data (screens, paper, texts) to whether the outcome is clinically validated assessment, like a PHQ-9 or simply text-based survey data, one sees a significant degree of variety.
As a web and mobile app-based offering, the Smart Omix team at Sharecare is naturally focused on screen-based reporting devices, like smartphones and tablets. The increase in the popularity of this category of ePRO could be attributable to smartphones and tablets offering flexibility, their increased ubiquity and improvements in digital literacy across participant demographics.
Despite these benefits however, the adoption and implementation of ePROs remains challenging. Some ePROs can simply be digitized surveys for participants to complete, making them no wider in scope than if a participant were to complete such a survey waiting in the clinic. It represents a missed opportunity. ePROs are also usually scheduled instruments in a study schedule; another missed opportunity. Participant-initiated ePROs that collect more than just the usual adverse event or hospitalization can create a rich source of data for a researcher such as possible side effects, new or unrecognized symptoms. Traditional ePROs often simply gather information on symptoms in one medium: text. One could argue that to truly understand symptoms - how they progress or regress, how burdensome they are, how they can fluctuate - they cannot simply exist on paper: symptoms, as often as they can be, ought to be heard, ought to be seen, and ought to be felt.
When our team was looking at solutions to these challenges, we looked across the industry for robust examples of how researchers have used different mediums and techniques to get more than just survey data from participants. The digital biomarkers development space has burgeoned in recent years, and several examples of how voice recordings have been used are notable. Our own work on ptosis detection among patients with generalized myasthenia gravis also provided us with real-world examples of how to collect video/photo selfie data.
With the many excellent examples available, we then moved to prioritizing how we wanted to reimagine the traditional ePRO. Some of the most important factors we considered:
- Scalability: Many researchers often have to develop voice, video, text, or photo ePROs from scratch every time. How could we build an ePRO that incorporated multiple types of media for the many different types of researchers on our platform? For instance, what could we build that would work for a real-world evidence/HEOR team, creating a novel objective symptom measure for FDA submission, and for a clinical marketing team collecting selfies and perception data on a new treatment for psoriatic dermatitis?
- Flexibility: Our team was eager to develop a software that wasn’t bound to a specific therapeutic area or type of study objective. How could we balance the customization, rigor, and specificity required by researchers conducting pivotal observational studies for a new drug and the less specific requirements of a PI running a pilot and feasibility study for a new drug indication?
- Configurability: To truly be ‘built for researchers, by researchers,’ our team felt it was crucial to put researchers in the driver’s seat. We wanted to open the door to researchers who might use our platform to create and validate new evidence-based assessments, or configure their collection of patient-reported data in new and exciting ways, like the voice-based PHQ-9 or GAD-7, instead of a screen-based offering.
- Affordability: There are rich, fascinating examples of institutions using expanded visions of patient-reported data to build digital biomarkers - arguably, the next frontier in precision medicine. We wanted to ensure that Smart Omix’s ePRO offering could evolve to serve not only large pharmaceutical companies and CROs, but also, mid-size biotechs, academic institutions and even individual clinical researchers.
Our first step in making those priorities a reality has been the reimagination of the traditional ePRO in the Smart Omix platform. We hope to give researchers a set of tools where:
- Compliance, security and accessibility is prized
- Every opportunity to collect data is an opportunity to engage participants
- The medium used for data collection can present more opportunity and possibility for every type of researcher, to democratize the creation of digital biomarkers or predictive models.
Today, we offer researchers 4 ePRO modules:
Basic ePROs - text-based collection of patient-reported data, with a starting set of 8 different question types that can be incorporated into any stage of the study schedule, whether building a patient intake form or a regularly scheduled assessment.
Rich ePROs - photo, video, and audio collection of patient-reported data. Researchers can add instruction screens and overlays to the collection of data with a few simple clicks.
Custom ePROs - for researchers reinventing how they want to capture patient-reported data entirely, our clinical team works hand-in-hand to build a custom ePRO that can be used for digital biomarker creation, and validated in hybrid and fully remote study settings for regulatory purposes.
AI ePROs - AI shouldn’t be an afterthought once a study has closed. We use proprietary neural nets and modules to use sensors to capture patient data. Explore our Smart Selfie, which translates a selfie into a predicted BMI, or Smart Medication, which turns a picture of a prescription pill bottle into medication information.
Explore building your own ePRO by signing up today.