Grounded in the 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.

DHT-derived measures capture dynamic changes in concepts such as physical activity, heart rate, etc., in real-world settings, providing insights into treatment effects and disease progression. Combined with other DHT-derived measures or traditional assessments such as COAs and/or biomarkers, these multimodal measures may improve clinical trial sensitivity, reduce patient burden, and provide a more complete view of disease and improve outcomes.

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.

Decode Obesity explores how digital measures can support obesity clinical trials by capturing meaningful, real-world data beyond traditional trial assessments. This talk will highlight the initiative, explore how digital measures can be implemented in GLP1 clinical trials, and discuss their potential impact on trial design, participant experience, data collection, and overall trial efficiency.

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.

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.

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.

Variability in clinician-administered clinical outcome assessments (COAs) remains a challenge in clinical research, directly impacting data quality, study sensitivity, and treatment effect detection. Having a “Rater Training service” is one of the ways to systematically standardize how clinicians administer and score COAs. To successfully launch an outsourced Rater Training service, organizations must establish a tight integration loop. This loop connects the scientific strategy of internal sponsor Subject Matter Experts with the operational scale and technical architecture of vendors.

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 the widespread use of imaging in clinical research and the existence of mature standards for medical image acquisition and interpretation, a harmonized set of imaging operations best practices in clinical trials has yet to be established. In this presentation, leaders from multiple organizations will share their thoughts on best practices.

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 and operations; reporting, analytics and quality monitoring; software build cycle time optimization; data management and statistical lock; and vendor management and governance.