Digital Endpoints in Decentralized Clinical Trials

This review examines digital endpoints in decentralized clinical trials. The organizing question is how sensor validity, missingness, participant burden, endpoint meaning, and operational reliability should be evaluated. Ten related scholarly sources are synthesized through a decision-centered framework spanning problem definition, mechanism, measurement, evaluation, implementation, and governance. The review does not invent experiments, pooled estimates, or unreported quantitative results. It instead evaluates the strength and transferability of the available evidence, with particular attention to using data volume as evidence of endpoint validity and patient relevance. The resulting framework links technical or empirical performance to explicit use conditions and identifies tests that should precede wider adoption in remote and hybrid clinical trials.

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8. Sacks, L., & Kunkoski, E. (2021). Digital Health Technology to Measure Drug Efficacy in Clinical Trials for Parkinson’s Disease: A Regulatory Perspective. Journal of Parkinson s Disease, 11(s1), S111-S115. https://doi.org/10.3233/jpd-202416 DOI
9. Solomon, J. J., Hallowell, R. W., Ganslandt, C., Shull, J. G., Bengtsson, T., Ganslandt, J., & Horton, M. R. (2024). A digital therapy targeting anxiety in pulmonary fibrosis: A decentralized randomized controlled trial. Respirology, 30(3), 253-261. https://doi.org/10.1111/resp.14859 DOI
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