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Regulatory considerations for successful implementation of digital endpoints in clinical trials for drug development

Year: 2025
Type: article
Abstract: Advances in Digital Health Technologies (DHTs) have opened new opportunities in clinical trials by providing innovative methods to collect information from participants 1 . DHTs consist of hardware and/or software and can be used on various computing platforms, such as mobile phones, smartwatches, etc. 2 , 3 . More advanced DHTs also leverage artificial intelligence and machine learning for data processing and analysis 4 . The use of DHTs in clinical trials offers several potential advantages by providing richer data sets (e.g., continuous data collection in participant’s home environment vs. snapshots/episodic recordings during clinical visits) or performing objective measurements without recall bias that flaws Patient Reported Outcomes, leading to a better understanding of the efficacy and safety of the interventions studied 1 , 3 , 5 , 6 . Via remote data acquisition, DHTs can also decrease the number of clinical trial sites and follow-up visits and potentially increase diversity and inclusivity in clinical trials 7 . For these and other advantageous reasons, we have seen the use of DHTs in clinical studies increase significantly over the years 1 , 8 , 9 , 10 . Recently, the first example of digital outcome assessment used in a pivotal study was completed, the Phase III REBUILD clinical trial of INOpulse for the treatment of fibrotic interstitial lung disease, the primary endpoint was the change in moderate to vigorous physical activity, as measured by actigraphy (NCT03267108). Unfortunately, the study failed to meet its primary endpoint.
DOI: 10.1038/s41746-025-01513-5
Language: English
Open Access status: gold
Estimated APC paid: $4,090
OpenAlex ID: W4408195864
FWCI: 8.713
Cites: 12
Cited by: 10
Related to: 10