Recruitment in pediatric clinical trials: an ethical perspective.

Abstract

There is a paucity of clinical trials in pediatric surgical disciplines. This is partly due to difficulties in recruiting participants. Frequently the origin of these problems lies in the ethical issues surrounding clinical trials in children. We reviewed the ethical barriers to recruitment in pediatric clinical trials and present recommendations to increase recruitment without violating accepted ethical boundaries. A literature search using the MEDLINE, EMBASE and Google engines was performed. All available North American guidelines were reviewed. Guidelines at a major North American center were also reviewed as an example of institutional directives. Seven categories of ethical issues hampering recruitment were identified. The perspectives of different investigators are discussed as well as their recommended practical approaches to resolve the issues. Several recommendations are presented to help investigators enhance approval and recruitment rates in clinical trials involving children.