Dr. Krista S. Leonard-Corzo recently delivered a presentation titled, “Partnerships for Developing Patient-Centric Digital Clinical Measures,” at the joint FDA/FNIH workshop for digital measures: Navigating the development of a digitally derived endpoint, emphasizing the critical role of collaboration in advancing digital health measure and endpoint development. When developing novel digital measures to be deployed within regulated clinical trials, strong efforts should be made to ensure that the measures are meaningful to the patient, clinically relevant, feasible, and both analytically and clinically valid. In the presentation, Dr. Leonard-Corzo shared an example of how VivoSense systematically approaches the process of developing patient-centric digital measures.
When building evidence for clinical validity of a novel digital measures, potential challenges may arise, particularly when no effective treatment or intervention exists, when incorporating existing anchor measures with known limitations, and when recruitment may be difficult (e.g., rare disease populations). Dr. Leonard-Corzo highlighted how building and maintaining strong partnerships between various stakeholders are essential for building the evidence-base for clinical validity of digital health measures and may help address these challenges. Specifically, the importance of early and continuous engagement with key stakeholders including patients and caregivers, patient advocacy groups, academic institutions, industry partners, and regulatory agencies.
Dr. Leonard-Corzo’s insights underscore the importance of patient and other key stakeholder input in the digital measure development process, aiming to improve patient outcomes through precise, relevant, and patient centric digital health measures.