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Review
. 2020 Aug;36(8):865-867.
doi: 10.1007/s00383-020-04665-5. Epub 2020 May 11.

Ethics of randomized trials in pediatric surgery

Rebecca M Rentea  1 , Tolulope A Oyetunji  2 , Shawn D St Peter  2
Affiliations
Review

Ethics of randomized trials in pediatric surgery

Rebecca M Rentea et al. Pediatr Surg Int. 2020 Aug.

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.

Keywords: Ethics; Pediatric surgery; Randomized control trial (RCT).

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