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Ethics of randomized trials in pediatric surgery

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.

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Contributions

Study conception and design: RMR. Acquisition of data: RMR. Analysis and interpretation of data: RMR, TAO, SDS. Drafting of manuscript: RMR, TAO, SDS. Critical revision of manuscript: RMR, TAO, SDS.

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Correspondence to Rebecca M. Rentea.

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All authors have no disclosures or conflicts of interest.

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Rentea, R.M., Oyetunji, T.A. & Peter, S.D.S. Ethics of randomized trials in pediatric surgery. Pediatr Surg Int 36, 865–867 (2020). https://doi.org/10.1007/s00383-020-04665-5

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Keywords

  • Ethics
  • Pediatric surgery
  • Randomized control trial (RCT)