2025 DIA Annual Meeting: The Importance of Early Patient Feedback in Digital Endpoint Development

In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer, uMotif, discussed how the company actively incorporates patient and site feedback throughout the digital health product lifecycle to ensure its tools are both accessible and intuitive. By involving end users early in the development process, uMotif aims to reduce burden on patients and clinical sites alike, while also ensuring that digital endpoints are usable, meaningful, and capable of standing up to regulatory scrutiny. Ongioni shared insights into the company's co-design strategies, real-world examples from clinical trials, and his perspective on the evolving role of artificial intelligence in enhancing patient-reported outcomes.

ACT: What role do patients and sites play in validating or adapting digital endpoints before they’re submitted to regulators or payers?

Ongioni: That really ties back to the Parkinson’s study example. We develop individual instruments—whether publicly available or licensed—and hold workshops and sessions with committees that are independent of any single study. These groups are willing and eager to provide feedback so that when these digital endpoints are ultimately used in a study, they are relevant and suitable for submission.

In one recent session, participants emphasized being cautious with their data—they don’t want to share it unless it will ultimately be acceptable for regulatory submission. Getting this early feedback and embedding it within the platform really helps ensure the data is useful and submissible.

Full Interview Summary: uMotif integrates patient and site feedback throughout the product development lifecycle to ensure its digital health tools are accessible, intuitive, and truly reflective of end-user needs. This is achieved through dedicated patient and site committees that collaborate with product teams early in the software design process. Whether it involves evaluating new features or reviewing early-stage prototypes, these stakeholders provide input that is incorporated before study-specific implementations, ensuring accessibility is embedded from the outset rather than added later.

A notable example of this co-design approach occurred during a Parkinson’s disease trial. Patients were given access to the platform before the study launched, allowing uMotif to make critical adjustments to accommodate their specific motor challenges. This included redesigning screen navigation and repositioning measurement tools to reduce burden and ensure data could be reliably collected for the intended endpoints.

Balancing patient usability with site workflows is also a core focus. uMotif developed a “hub model” to streamline the experience for clinical sites, consolidating disparate systems into a unified platform. By observing and incorporating site input—such as understanding their daily routines and workflow priorities—the company optimized functionality to reduce administrative burden. This site-and-patient-first mindset extends to the validation of digital endpoints, where uMotif organizes separate workshops for patient and site committees to provide feedback on new instruments, ensuring their relevance, usability, and potential regulatory acceptability.

Looking ahead, uMotif sees artificial intelligence and machine learning playing an increasingly important role in refining patient-reported outcomes. These technologies could support the transition from paper to electronic formats and enhance scalability. While there’s ongoing skepticism, AI has the potential to help surface what matters most to patients by amplifying their voices throughout the development lifecycle, provided it is implemented thoughtfully and iteratively.