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Background <p>Children are increasingly involved in clinical trials, yet their own perspectives on participation are often overlooked in favor of parental or professional views. Understanding children’s lived experiences is essential for improving trial design and ethical practice.</p> Methods <p>We conducted a systematic review and qualitative evidence synthesis of studies exploring children’s experiences and perspectives regarding clinical trial participation. We searched PubMed, Embase, APA PsycInfo, APA PsycArticles, CINAHL, Web of Science, and three Chinese databases from inception to January 1, 2026. Two reviewers independently screened studies, extracted data, and assessed quality. Data were synthesized using the thematic synthesis method and confidence in the findings was assessed using the GRADE-CERQual approach.</p> Results <p>A total of 56 qualitative interview studies involving 2,101 children from 15 different countries were included.The synthesis identified three overarching analytic dimensions that frame the child’s participation journey: (1) Negotiating Agency within Information Asymmetry, where children strive for control despite limited understanding; (2) Relational Autonomy in the Child-Parent-Professional Triad, highlighting that children’s decision-making is deeply embedded in social relationships; and (3) The Dynamic Balance of Burden and Altruism, where children continuously weigh personal risks against altruistic benefits. These dimensions encompassed six descriptive themes: children’s understanding of trial components; requests for personal rights; influence of other people; potential benefits; potential concerns; and the trial participation experience.</p> Conclusions <p>Children’s participation in clinical trials is not a single decision but a dynamic, relational process. The findings support a shift from protecting children from research to protecting them through ethical engagement. Researchers should adopt a stance of “ethical symmetry,” treating children’s assent with the same ethical gravity as adult consent, and facilitate “relational autonomy” by supporting the child-parent-professional triad. Tailored, age-appropriate information and continuous emotional support are critical to optimizing children’s trial experiences.</p>

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Experiences and perspectives of children and adolescents participating in pediatric clinical trials: a qualitative evidence synthesis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月31日

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  • Yiming Ren,
  • Si Tang,
  • Guanghe Ji,
  • Rui Li,
  • Jianping Liu,
  • Ruyu Xia,
  • Yutong Fei

摘要

Background

Children are increasingly involved in clinical trials, yet their own perspectives on participation are often overlooked in favor of parental or professional views. Understanding children’s lived experiences is essential for improving trial design and ethical practice.

Methods

We conducted a systematic review and qualitative evidence synthesis of studies exploring children’s experiences and perspectives regarding clinical trial participation. We searched PubMed, Embase, APA PsycInfo, APA PsycArticles, CINAHL, Web of Science, and three Chinese databases from inception to January 1, 2026. Two reviewers independently screened studies, extracted data, and assessed quality. Data were synthesized using the thematic synthesis method and confidence in the findings was assessed using the GRADE-CERQual approach.

Results

A total of 56 qualitative interview studies involving 2,101 children from 15 different countries were included.The synthesis identified three overarching analytic dimensions that frame the child’s participation journey: (1) Negotiating Agency within Information Asymmetry, where children strive for control despite limited understanding; (2) Relational Autonomy in the Child-Parent-Professional Triad, highlighting that children’s decision-making is deeply embedded in social relationships; and (3) The Dynamic Balance of Burden and Altruism, where children continuously weigh personal risks against altruistic benefits. These dimensions encompassed six descriptive themes: children’s understanding of trial components; requests for personal rights; influence of other people; potential benefits; potential concerns; and the trial participation experience.

Conclusions

Children’s participation in clinical trials is not a single decision but a dynamic, relational process. The findings support a shift from protecting children from research to protecting them through ethical engagement. Researchers should adopt a stance of “ethical symmetry,” treating children’s assent with the same ethical gravity as adult consent, and facilitate “relational autonomy” by supporting the child-parent-professional triad. Tailored, age-appropriate information and continuous emotional support are critical to optimizing children’s trial experiences.