Ethics of randomized trials in pediatric surgery.

Document Type

Article

Publication Date

8-2020

Identifier

DOI: 10.1007/s00383-020-04665-5

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.

Journal Title

Pediatric surgery international

Volume

36

Issue

8

First Page

865

Last Page

867

Keywords

Ethics; Pediatric surgery; Randomized control trial (RCT)

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