ArticlePloS one2025
Evolving demographics of eligible patient population can impact enrollment of a biomarker clinical study.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.
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1 citing paper in PubMed, 1 synthesis or guideline pooled it.
- P300 Event-Related Potentials as Cognitive Biomarkers in Neurological and Neuropsychiatric Disorders: A Systematic Review.Revista de neurologia · 2026Pooled it
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5 authors.
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Abstract
In a prospective clinical study to better understand how biological markers can improve diagnosis of and prognosis for asthmatic and atopic conditions, we contacted over 3500 eligible patients and observed noticeable differences in the range of their likelihood to enroll based on gender (3.8-13.4%), race and ethnicity (4.8-29.8%), and distance to study site (1.1-29.2%). Both the eligible patients and enrolled participants exhibited a more diverse racial and ethnic composition compared to local population demographics. Based on the eligible patients that the study team contacted ("eligible patients", n = 3648) and those who agreed to enroll ("enrolled participants", n = 454), we analyzed the gender, age, race and ethnicity composition of the groups, together with their proximity to the study site. Living close to the study site was the largest contributor to a patient's decision to enroll for both adults (odds ratio OR: 2.26, 95% confidence interval CI: 1.64-3.15, p < 0.001) and children (OR: 2.59, 95% CI: 1.67-4.41, p < 0.001). We also observed that patients from White and non-Hispanic racial and ethnic background were more likely to participate in the study among both pediatric (OR: 1.51, CI: 0.92-2.62, p = 0.122) and adult patients (OR: 1.81, CI: 1.18-2.89, p = 0.009). Eligible patients of female gender were also more likely to enroll in both adult (OR: 1.53, CI: 1.16-2.05, p = 0.003) and pediatric groups (OR: 2.14, CI: 1.42-3.22, p < 0.001). Overall, the pediatric patients (18 years old or younger) were much less willing to participate in the clinical biomarker study. Nonetheless, as they age, the enrollment likelihood increased accordingly (5 years OR: 1.71, CI, 1.32-2.21, p < 0.001). The eligible patient population of the study reflected the evolving demographics and different disease prevalence for asthma and other allergic diseases in adult and pediatric groups. These factors in turn influenced the composition of the enrolled participants.
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