ArticleTherapeutic advances in drug safety2025
Impact of social determinants of health on safety of patients in device clinical trials conducted at a safety-net hospital.
Article in Therapeutic advances in drug safety, 2025. 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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3 authors.
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Abstract
Background: Underrepresentation of various populations in clinical trials limits our understanding of efficacy and safety outcomes, as individuals with diverse backgrounds can respond differently to the same interventions. Inclusion of diverse groups in device clinical trials is essential for providing innovative, patient-centric solutions and achieving health equity. Objective: To evaluate how social determinants correlate with safety events in clinical trials with medical devices to identify safety signals, improve safety profiles, and develop risk-based safety and quality management strategies. Design: A single-center, retrospective study was conducted for clinical trials with medical devices at a safety-net hospital. Methods: Data obtained from 223 patients randomized into 19 device clinical trials were assessed retrospectively for correlation of social determinants of health variables and study protocol complexity with study protocol deviations, adverse events, and study dropout rates by using the Kruskal-Wallis and Spearman correlation tests. Results: Lower median income was associated with an increased number of adverse events ( Conclusion: Examining the root causes of these outcomes, as well as patient-centric medical management, can improve data integrity and aid risk-based safety and quality management in device clinical trials.
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