Grounded in FDA’s Patient-Focused Drug Development framework, this session highlights a mixed methods approach to generating evidence for digital outcome measures. Using a non-interventional study, we demonstrate how deployment of actigraphy in patients, qualitative interviews, and exploratory quantitative analyses inform meaningfulness of digital measures to patients, DHT usability, and feasibility, strengthening the evidentiary foundation to support the value of digital measures to derive meaningful endpoints in future clinical trials.

Digital health technologies enable continuous, objective measurement of motor and non-motor function in Parkinson's disease, offering greater sensitivity to change than episodic in-clinic assessments. This presentation describes the Neuron23–Roche collaboration deploying sensor-derived digital measures in the NEULARK Phase 2 trial in early Parkinson's disease, including endpoint selection, fit-for-purpose validation, and clinical operations deployment—illustrating how digital measures can de-risk development and increase the probability of trial success.

Controlled UVB exposure was used to evaluate non-invasive digital measures of acute skin erythema and barrier disruption in 12 healthy adults. Transepidermal water loss (TEWL) and image-based redness increased significantly with UVB dose, whereas SciBase scores and hydration measurements showed limited dose responses. TEWL and image-based redness also tracked longitudinal changes after 2xMED exposure. These findings support further development of imaging and TEWL as feasible endpoints for dermatology trials.

Digital health technologies offer the potential to track Parkinson's disease progression with greater objectivity, sensitivity, and precision than traditional clinical assessments. This presentation will describe a framework for developing composite digital measures (CDMs) that integrate multiple measures of motor function using longitudinal study data. We will discuss the potential of CDMs to support more efficient clinical trials and review key validation considerations.

IBD activity and treatment response are typically assessed through sporadic testing and infrequent visits to clinical sites. In a collaborative study, wearables were used to continuously measure sleep, heart rate, and heart rate variability in patients starting biologic therapy. Improved wearable-derived sleep and physiological signals were associated with response and remission, while worsening signals reflected ongoing inflammation, supporting wearable-derived biomarkers for proactive remote IBD monitoring.

More than 50 percent of all clinical studies use medical imaging to evaluate the efficacy of new drugs and devices, with utilization reaching as high as 95 percent in oncology trials. Despite widespread use of imaging in clinical research and existence of mature standards for medical image acquisition and interpretation, a harmonized set of imaging operations best practice within clinical trials has yet to be established. In this presentation, leaders from multiple organizations will share their thoughtwork on best practice.

To build a highly efficient, audit-ready electronic Clinical Outcome Assessments (eCOA) ecosystem, clinical teams must integrate clinical operational needs with technical software architectures. Pfizer has consolidated the best practices across the six core pillars of a comprehensive eCOA strategy including patient centric solution design; project management & operations; reporting, analytics & quality monitoring; software build cycle time optimization; data management & statistical lock; and vendor management & governance.