ArticleTherapeutic innovation & regulatory science2026
How Digital Health Technologies have been Used to Support Regulatory Drug Approval.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
3 authors.
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Abstract
objectiveThe integration of Digital Health Technologies (DHTs) in clinical trials enhances patient recruitment, streamlines data collection, and provides new endpoints. However, a complex regulatory environment limits their adoption. This report reviews how DHTs have supported regulatory decision-making for drug marketing authorization in the US and Europe, detailing the types and purposes of DHTs utilized.
methodsOur analysis using Cortellis® examined drug approvals from September 2021 to March 2025, featuring a quantitative review of 60 DHT-related approvals and qualitative case studies.
resultsOf the 60 approvals, 39 (63%) were granted by the EMA and 23 (37%) by the FDA. The predominant DHTs were ePRO tools (70%), with smartphones (66%) as the leading platform. Most DHTs were used in Phase 3 trials (82%) primarily for collecting safety and efficacy data. Notably, no approvals were based solely on DHT-derived primary endpoints. Case studies illustrate the tools' nature and highlight the importance of interaction with health authorities for successful implementation. An analysis of DHT use in clinical trials for investigational drugs on ClinicalTrials.gov showed five references where digital biomarkers were measured through DHTs, while no references for digital biomarkers were found in the approval reports.
conclusionDHTs are regularly used by clinical trial sponsors and acknowledged by authorities for regulatory decision-making. Current approvals mainly involve ePRO tools with limited capabilities. The landscape is evolving; more sophisticated digital evidence generation tools are emerging, such as sensor-based DHTs (sDHT) and Artificial Intelligence/Machine Learning (AI/ML). Close collaboration between industry and regulators is vital for developing DHT qualification pathways.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.