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Improving Clinical Trial Recruitment and Retention in Pediatric Rheumatology

Duke Clinical Research Institute

The Challenge

Recruiting and retaining children with juvenile idiopathic arthritis (JIA) into clinical trials has long been a barrier to advancing treatment. For newly diagnosed families, the challenge is heightened: parents are overwhelmed, often mistrustful of research, and unprepared to make decisions about enrollment in randomized controlled trials (RCTs).

Traditional recruitment tools—brochures, diagrams, and educational handouts—often fall short. They may be misunderstood, fail to build trust, or overlook the emotional realities families face at diagnosis. Without a better approach, promising therapies risk delayed development, and children who could benefit may never gain access.

Goals

Working with Duke Clinical Research Institute, the Childhood Arthritis and Rheumatology Research Alliance (CARRA), and Bristol-Myers Squibb, LIFT set out to advance understanding of the lived experience at the time of JIA diagnosis, capture how parents and caregivers make decisions about RCT participation, identify barriers and facilitators to recruitment and retention, and ultimately inform the design and refinement of shared decision-making (SDM) tools to improve trial engagement in JIA and beyond.

Objectives

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Develop shared decision-making tools that educate prospective participants on the clinical trial and reflected the needs and expectations of parents and caregivers of children with JIA.
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Establish shared processes to be utilized by physicians and site staff to effectively engage prospective trial participants and their families.
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Improve trial recruitment and retention efforts, leading to a successful clinical trial.

Method

LIFT designed a mixed-methods qualitative study embedded within the Limit JIA clinical trial. This study included digital ethnographic immersions, which allowed researchers to engage in  observations, interviews, and elicitation exercises capturing families’ lived realities and emotional states around diagnosis and trial decision-making.

Some families participated in the study via telephone interviews, which were designed to explore parental decision-making in a lower-burden format. Additionally, electronic surveys, tailored for families, clinicians, site investigators, and research coordinators aimed to identify barriers and gaps across the trial ecosystem.

The findings of the qualitative study were used to inform PDSA cycles, which are iterative design and feedback loops to test and refine recruitment tools in real time.

Deliverables

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MarketVoice Report
A thematic insights report, detailing the study findings in plain language that assured accessibility amongst multiple stakeholder groups, including clinical trial primary investigators, parents and caregivers, patients, etc.
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Design Workshops
Facilitated in-person and digital stakeholder workshops that engaged multiple stakeholder types in the PDSA cycle process, informing the shared decision-making tool content and design.
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Creative Tools
Multiform shared decision-making tools, including printed materials, digital content, and educational videos, that reflected the needs of the unique audience (parents of children with JIA at the time of diagnosis).

Outcome

This study facilitated the shaping and design of new decision-support tools for families and site teams, grounded in lived experience rather than assumptions. This resulted in recruitment materials that were culturally attuned, emotionally relevant, and more effective in building trust.

Additionally, the study led to process improvements for site investigators and coordinators to approach families with empathy and clarity, and presented a replicable framework that can be applied to other pediatric conditions where recruitment and retention are a challenge.

By embedding ethnographic insight into clinical trial design, this collaboration addressed one of the most persistent barriers in pediatric research: how to meet families at the moment of greatest uncertainty with information and support that feels human, trustworthy, and relevant. The result was not just better recruitment—it’s a more equitable, patient-centered path to advancing therapies for children with JIA and beyond.