Digital Endpoints in Decentralized Clinical Trials
Keywords:
digital endpoints, decentralized trials, wearables, validation, clinical researchAbstract
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.
References
- Braley, M., Pierce, J. S., Saxena, S., Oliveira, E. D., Taraboanta, L., Anantha, V., Lakhan, S. E., & Kiran, S. (2021). A Virtual, Randomized, Control Trial of a Digital Therapeutic for Speech, Language, and Cognitive Intervention in Post-stroke Persons With Aphasia. Frontiers in Neurology, 12, 626780. https://doi.org/10.3389/fneur.2021.626780
- Chodankar, D., Raval, T. K., & Jeyaraj, J. (2023). The role of remote data capture, wearables, and digital biomarkers in decentralized clinical trials. Perspectives in Clinical Research, 15(1), 38-41. https://doi.org/10.4103/picr.picr_219_22
- Coyle, J., Rogers, A., Copland, R., Paoli, G. D., MacDonald, T. M., & Mackenzie, I. S. (2021). Learning from remote decentralised clinical trial experiences: A qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders. British Journal of Clinical Pharmacology, 88(3), 1031-1042. https://doi.org/10.1111/bcp.15003
- Kasahara, A., Mitchell, J., Yang, J., Cuomo, R. E., McMann, T. J., & Mackey, T. K. (2024). Digital technologies used in clinical trial recruitment and enrollment including application to trial diversity and inclusion: A systematic review. Digital Health, 10, 20552076241242390. https://doi.org/10.1177/20552076241242390
- Kruizinga, M. D., Stuurman, F. E., Exadaktylos, V., Doll, R. J., Stephenson, D. T., Groeneveld, G. J., Driessen, G. J. A., & Cohen, A. F. (2020). Development of Novel, Value-Based, Digital Endpoints for Clinical Trials: A Structured Approach Toward Fit-for-Purpose Validation. Pharmacological Reviews, 72(4), 899-909. https://doi.org/10.1124/pr.120.000028
- Masanneck, L., Gieseler, P., Gordon, W. J., Meuth, S. G., & Stern, A. D. (2023). Evidence from ClinicalTrials.gov on the growth of Digital Health Technologies in neurology trials. npj Digital Medicine, 6(1), 23. https://doi.org/10.1038/s41746-023-00767-1
- Mittermaier, M., Venkatesh, K. P., & Kvedar, J. C. (2023). Digital health technology in clinical trials. npj Digital Medicine, 6(1), 88. https://doi.org/10.1038/s41746-023-00841-8
- 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
- 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
- Tan, R. K. J., Wu, D., Day, S., Zhao, Y., Larson, H. J., Sylvia, S., Tang, W., & Tucker, J. D. (2022). Digital approaches to enhancing community engagement in clinical trials. npj Digital Medicine, 5(1), 37. https://doi.org/10.1038/s41746-022-00581-1
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