Ethics of randomized trials in pediatric surgery
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In brief
In brief
This review examines the unique ethical challenges in conducting randomized controlled trials in pediatric surgery, including low patient volumes, parental consent complexities, recruitment difficulties, and investigator bias. Understanding these considerations is essential for surgeons designing rigorous comparative studies to evaluate surgical innovations and establish evidence-based treatment protocols for children.
Written by the GCMD Library team from the article.
Abstract
To provide the best evidence-based treatment for children, and timely evaluation of innovations, the role of the pediatric surgeon’s participation in randomized controlled trials (RCTs) and prospective comparative studies is required. The ethical considerations of pediatric surgical RCTs pose unique practical difficulties in the design and performance of clinical trials in children. There are several ethical issues unique to pediatric surgical RCTs: diseases with low volume, an inability to conduct Phase 1 and 2 trials, parental emotional involvement, difficulty with recruitment in surgical trials, volume, and modified study design, issues with permission vs. assent and investigator bias. This article reviews the ethical aspects unique to pediatric surgical RCTs and prospective comparative studies.
Level of evidence: Level 3.