Strategies to Increase Enrollment and Retention in Pediatric Clinical Research: A Scoping Review.

Abstract

Lack of participant diversity in pediatric clinical research limits external validity of findings and can exacerbate health inequities. Our objective was to identify evidence-based strategies/interventions that improve enrollment and retention of diversity of pediatric participants in clinical research and provide an evidence-based tool to guide pediatric clinical research protocols. This study comprised a scoping review of peer-reviewed literature that reported methods to increase enrollment and retention of pediatric participants in clinical research (2009-2022). Guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews. Data extraction included quantitative and qualitative outcomes. Eligible studies' findings were analyzed and grouped into specific attrition steps that limit pediatric clinical research participants' enrollment and retention. A total of 31 studies met inclusion criteria. Each study's insights were categorized based on attrition steps that limited pediatric participant diversity: study design (n = 1), marketing/outreach strategies (n = 7), participant perceptions (n = 9), consent/enrollment issues (n = 8), incentives/reimbursements mechanisms (n = 4), retention strategies (n = 8), and follow-up/feedback channels (n = 3). Many studies had overlapping attrition categories. Most studies were nonrandomized clinical studies such as retrospective and cohort studies with different strategies/interventions, making comparisons between studies challenging. The effectiveness in recruiting a diverse cohort of pediatric clinical research participants requires a multifaceted approach addressing issues at every stage of the clinical research process. Enrollment and retention strategies should focus on building trust, providing effective incentives, and incorporating continuous feedback.