Perceived Barriers to Clinical Trials Participation: A Survey of Pediatric Caregivers

Authors

  • Natalie Sollo, M.D. University of Kansas School of Medicine-Wichita
  • Carolyn R. Ahlers-Schmidt, Ph.D. University of Kansas School of Medicine-Wichita
  • Ann M. Davis, Ph.D. Center for Children's Healthy Lifestyles & Nutrition, University of Kansas Medical Center, Kansas City, KS
  • Timothy Ryan Smith, M.D. Center for Children's Healthy Lifestyles & Nutrition, University of Kansas Medical Center, Kansas City, KS
  • Julian Dedeaux, Ph.D. KU School of Medicine Wichita
  • Russell J. McCulloh, M.D. Pediatrics, Children's Hospital and Medical Center, University of Nebraska Medical Center, Omaha, NE

DOI:

https://doi.org/10.17161/kjm.vol15.16220

Keywords:

pediatric, clinical trials, enrollment, caregiver

Abstract

Introduction. Pediatric clinical trials are difficult to conduct, leading to off-label use of medication in children based on results of trials with adults. As a unique population, children deserve to have appropriately tested therapies. The purpose of this study was to evaluate pediatric caregivers’ beliefs and perceived barriers to participation in clinical trials.

Methods. The study was completed within the Sunflower Pediatric Clinical Trials Research Extension (SPeCTRE), an affiliate of the IDeA States Pediatric Clinical Trials Network (ISPCTN). This was a cross-sectional survey, adapted from the Pediatric Research Participation Questionnaire. A convenience sample of pediatric caregivers was recruited in three areas of a highly rural Midwestern state between 2017 and 2018.

Results.  A total of 159 caregivers completed surveys; the majority (72.3%) were previously familiar with clinical trials, but <20% had ever been invited to participate. Caregivers were willing to consider enrolling their child if a physician in whom they had high trust recommended the trials (H=10.1, p=0.04) and if there were perceived benefits, such as access to tests and medications not covered by insurance (correlation coefficient [CC]=0.4, p<0.01) and compensation for time and travel (CC=0.3, p=0.04).

Conclusions. Trust in their physician highly influences likelihood of a caregiver consenting to have their child participate in a clinical trial. Therefore, to facilitate opportunities for children to participate in clinical trials, physicians need to be trained so they can offer trials locally. In addition, trials need to offer benefits, such as increased access to tests and medications as well as appropriate compensation.

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Published

2022-04-29

How to Cite

Sollo, N., Ahlers-Schmidt, C., Davis, A., Smith, T., Dedeaux, J., & McCulloh, R. (2022). Perceived Barriers to Clinical Trials Participation: A Survey of Pediatric Caregivers . Kansas Journal of Medicine, 15(1), 139–143. https://doi.org/10.17161/kjm.vol15.16220

Issue

Section

Original Research