Talk Main Conference CDISC track
From Wearables to Regulatory Submissions: The Evolving Role of Digital Health Technologies in Clinical Research
Mon, Oct 5, 2026 · 5:00–5:30 PM MDT Evergreen C, Denver Marriott Tech Center
About this session
Part of Session 4, Track C: RWD/DCT (Chair: Donna Sattler, Eli Lilly).
Digital health technologies (DHTs) spanning wearables, eCOA platforms, mobile applications, and remote monitoring sensors are fundamentally transforming clinical trial design and evidence generation. DHT adoption in registered trials grew from under 1% in 2010 to over 11% by 2020, with decentralized trial market projections reaching $38 billion by 2034. The FDA's 2024 final guidance on decentralized clinical trials established validation, reliability, and oversight expectations for DHTs, while ICH E6(R3) formalized eSource's role in GCP-compliant research. Early adopters report 50% faster enrollment and up to 25% cost reductions. However, standardizing DHT-generated continuous
data streams into CDISC CDASH and SDTM-compliant formats remains an unresolved operational challenge, particularly for novel digital endpoints. This presentation examines the current regulatory
framework for DHTs, real-world implementation experience, challenges in digital endpoint harmonization, and the path toward CDISC-aligned data architectures that enable DHT-sourced evidence to meet submission-readiness standards.
Speaker
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Hexaware Technologies
Speaker
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