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Why do children decide not to participate in clinical research: a quantitative and qualitative study

Irma M Hein1, Pieter W Troost1, Martine C de Vries2

  • 1Department of Child and Adolescent Psychiatry, Academic Medical Center, Amsterdam, The Netherlands.

Pediatric Research
|April 10, 2015
PubMed

Insights

Pediatric clinical trial participation is low, with younger children and those with less disease experience being less likely to enroll. Addressing time constraints and logistical burdens is key to improving recruitment for pediatric research.

Area of Science:

  • Pediatric clinical research
  • Clinical trial recruitment
  • Patient participation

Background:

  • Pediatric drug trials are essential but face significant recruitment challenges.
  • Regulatory requirements ensure safety but do not resolve participation barriers.
  • Understanding nonparticipation factors is crucial for optimizing pediatric clinical research.

Purpose of the Study:

  • To identify factors influencing nonparticipation in pediatric clinical research.
  • To provide evidence-based recommendations for improving pediatric patient recruitment strategies.

Main Methods:

  • A prospective study was conducted from January 2012 to January 2014.
  • 161 pediatric patients aged 6-18 eligible for research were analyzed.
  • Quantitative analysis of variables (age, cognitive development, experience, ethnicity) and qualitative interviews explored reasons for nonparticipation.

Main Results:

  • Sixty percent of eligible children did not participate (39% declined, 21% undecided).
  • Younger age, less disease experience, and simpler, lower-risk studies predicted nonparticipation.
  • Time constraints and perceived extra burden were primary reasons for nonparticipation.

Conclusions:

  • Recruitment strategies should target younger children and families facing logistical and informational barriers.
  • Recommendations include enhancing communication on research value, minimizing participant burden, and improving accessibility.
  • Optimizing recruitment requires addressing practical challenges for pediatric participants and their families.
Abstract

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