12:00am Thursday 17 October 2019

UC Davis study finds disparities in clinical trial consent process

(SACRAMENTO, Calif.) — Researchers at UC Davis and other institutions have found that clinicians in a multicenter pediatric trial failed to get consent from black and Hispanic parents at higher rates than white parents.

JoAnne Natale

JoAnne Natale

Analyzing data from the RESTORE trial, which studied a new sedation protocol for children who were being mechanically ventilated, the researchers determined that 19.5 percent of black parents, whose children were eligible for the study, were never approached about the trial. By contrast, 13.2 percent of Hispanic and 11.7 percent of white parents were not approached. In addition, 29.5 percent of the black parents who were approached refused consent, compared to 25.9 percent of Hispanic and 18.2 percent of white parents. The study was published in The Journal of Pediatrics.

“A large proportion of the subjects could not be enrolled, and that is a missed opportunity,” said JoAnne Natale, professor, director of Quality and Safety at UC Davis Children’s Hospital and first author on the paper. “As a result, from a race and ethnicity standpoint, the patients enrolled in this study do not represent the population at large, and the conclusions you draw may not be generalizable to that broader population.”

The RESTORE trial studied more than 2,400 children, of 3438 who met the enrollment criteria, at 31 sites around the United States. In their analysis, the team investigated two elements of consent: whether parents were approached and, if they were, did they give consent.

In many ways, RESTORE was the ideal study to analyze. The sedation protocol being investigated neither posed significant risk, which might deter participation, nor was it potentially life-saving, which might significantly encourage consent.

Of the black parents who could not offer consent, 54.3 percent were physically unavailable, compared to 45.5 percent of Hispanic and 40.8 percent of white parents, and 22 percent had guardianship issues, compared to 19.4 percent of white and 11.8 percent of Hispanic parents.

Though the findings may indicate potential bias in how consent is obtained, the data does not illuminate the individual situations that drive these results. Natale cautions that parents might not be at their child’s bedside for a variety of reasons.

“There are many reasons some parents are not able to spend long hours at their child’s bedside where we would approach them for participating in a clinical trial. For example, some parents live many hours away from the hospital where their child is being cared for and transportation is expensive or not readily available. For others, they work in jobs that do not provide paid days off when a child is ill. These parents cannot afford to be away from work.”

However, the authors believe this new data offers a great opportunity to redesign trials to both reach these families and provide better information to encourage their consent.

“If non-whites are not approached to participate in clinical trials, they can’t say yes,” said Natale. “And their child is missing the chance for benefit from being part of the clinical trial. We need to be thinking about these issues up front and looking at interventions that will help ameliorate these disparities.”

Other authors included Jill G. Joseph at UC Davis; Ruth Lebet and Martha A.Q. Curley at the University of Pennsylvania, Christine Ulysse and David Wypij, at Harvard University; and Judith Ascenzi at John’s Hopkins University.

This research was funded by grants from the National Institutes of Health (U01 HL086622, U01 HL086649 and UL1 TR000002).
UC Davis Children’s Hospital is the Sacramento region’s only nationally ranked, comprehensive hospital providing care for infants, children, adolescents and young adults with primary, subspecialty and critical care. It includes the Central Valley’s only pediatric emergency department and Level I pediatric trauma center, which offers the highest level of care for its critically ill patients, as well as the West Coast’s only Level I children’s surgery center. The 129-bed children’s hospital includes the state-of-the-art 49-bed neonatal and 24-bed pediatric intensive care and pediatric cardiac intensive care units. For more information, visit children.ucdavis.edu.Centro de Tecnología y Ciencia Biofotónica (CBST)

Share on:

MORE FROM Legal and Regulatory

Health news