Abstract Details

Title Protecting Vulnerable Populations in Clinical Research: Are Children or Adults More At-risk for Non-compliance in Neurologic Protocols?

Topic Practice, Policy, and Ethics

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 10-004

Objective The objective of this single-center study was to compare non-compliance events in vulnerable populations of children and adults participating in neurologic research protocols.

Background Clinical non-compliance with pediatric patients has been well documented, with studies identifying logistical and pharmaceutical issues across countries, notably Saudi Arabia, India, and the United Kingdom. However, additional work is needed to determine the occurrence of pediatric non-compliance in the United States to protect this vulnerable population in neurologic research.

Design/Methods A retrospective, cross-sectional cohort study design was used to compare non-compliance across vulnerable populations. Non-compliance was categorized by the type of population enrolled in each study and the non-compliance type, primary category, and cause. Non-compliance rates of the pediatric and adult cohorts were analyzed by calculating comparisons of two rates, incidence rate ratios (IRRs), and 95% confidence intervals.

Results Overall, 368 non-compliance events occurred across 2,544 participants. Fourteen events occurred across 25 participants in the pediatric cohort (0.56 events/participant), whereas 354 events occurred across 2,519 participants in the adult cohort (0.14; p<0.001; IRR=3.98 [2.16-6.78]). Minor non-compliance was more likely to occur in the pediatric cohort (0.56 vs. 0.13; p<0.001; IRR=4.37 [2.36-7.44]). Protocol non-compliance (0.32 vs. 0.12; p=0.02; IRR=2.60 [1.11-5.19]), specimen collection (0.20 vs. 0.003; p<0.001; IRR=71.97 [18.01-263.43]), and breach of personally identifiable information (0.04 vs. 0.002; p=0.07; IRR=16.79 [0.37-138.42]) were more likely to occur in the pediatric cohort (pediatric vs. adult, respectively). Lastly, pediatric non-compliance was more likely to be caused by COVID-19 (0.12 vs. 0.07; p=0.38; IRR=1.66 [0.34-4.93]), the research participant (0.24 vs. 0.03; p<0.001; IRR=8.40 [2.98-19.19]) and the study team (0.16 vs. 0.02; p<0.01; IRR=9.16 [2.39-25.16]).

Conclusions Pediatric research participants are more likely to experience certain types of non-compliance when compared to adults. The potential for under-reporting is also a factor in this population. Clinical research teams should proactively amend protocols to prevent non-compliance and prioritize safety.

Authors/Disclosures
Matthew Gooden PRESENTER	Matthew Gooden has nothing to disclose.
Katherine Landry (Clinical Trials Unit - NINDS - NIH)	No disclosure on file
Gina Norato	Gina Norato has nothing to disclose.
Sandra Martin (National Institutes of Health)	Sandra Martin has nothing to disclose.
Henry Roberts (National Institutes of Health)	No disclosure on file
Lauren Reoma, MD, FAAN (NIH/NINDS)	Dr. Reoma has received research support from NIH. Dr. Reoma has a non-compensated relationship as a Vice Chair with AAN Experimental Neurotherapeutics Section that is relevant to AAN interests or activities. Dr. Reoma has a non-compensated relationship as a Federal Employee with NINDS/NIH that is relevant to AAN interests or activities. Dr. Reoma has a non-compensated relationship as a Member with ASENT Program Committee that is relevant to AAN interests or activities.

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