Professor of Pediatrics University of Utah School of Medicine Park City, Utah, United States
Background: Clinical trial interruptions and reduced patient enrollments have serious negative effects on the advancement of clinical science. As such, the COVID-19 pandemic has caused tremendous disruptions to non-COVID-19 clinical research. Furthermore, there has been consensus among investigators that consent rates for randomized clinical trials (RCT) have dropped following the pandemic. However, there has been little investigation on how parents/guardians have responded to clinical trial recruitment following the COVID-19 pandemic in neonatal populations. Objective: To compare the effect of the COVID-19 pandemic on rates of eligible patient consent to 2 similar RCTs carried out at 5 academic centers in Utah during 2 distinct epochs: 2012-2014 and 2022-2024. Design/Methods: Retrospective study comparing total number of consents and refusals to enrollment and total number of parents/legal guardians of eligible babies screened and approached for the “Darbepoetin Administration to Neonates Undergoing Cooling for Encephalopathy” (DANCE)(2012-2014) and the “Dexmedetomidine Use in Infants undergoing Cooling due to Neonatal Encephalopathy” (DICE)(2022-2025) trials. Both trials had similar characteristics: Phase II safety and pharmacokinetics trials enrolling 30-50 babies with neonatal encephalopathy undergoing cooling for 72 hours; timing to approach and consent within 24 hours of life; and the same group of research coordinators and neonatologists involved in the consent process. Chi-square test was used for statistical analysis. Results: For the DANCE trial, 62 infants with NE were screened at participating centers, informed parental consent was obtained for 30 infants, 14 parents declined participation, 8 parents were unavailable, and 10 infants became ineligible post-initial screening process (exclusion criteria). That represents a 69% consent rate obtained in the first 12 hours of life. In contrast, for the DICE trial, 150 infants with NE were screened at the 5 participating NICUs, 81 parents declined participation, and 20 infants became ineligible post-initial screening process (exclusion criteria). That represents a 38% consent rate obtained in the first 24 hours of life (p 0.0006). There was no significant difference in the demographic characteristics of both groups.
Conclusion(s): This is the first report that shows significantly different consent rates for 2 similar RCT interventional trials in the neonatal population carried before and after the COVID-19 pandemic. The reason behind the drop in consent rates is still unclear.The information obtained may help in the design of future trials and consent approach.
Table 1. Randomized controlled trials and rates of consent per trial consent rates table PAS 2026.pdfDANCE= Darbepoetin Administration to Neonates Undergoing Cooling for Encephalopathy; DICE= Dexmedetomidine Use in Infants undergoing Cooling due to Neonatal Encephalopathy
