Resumen

BUENO RODRIGUEZ, José Carlos. Clinical trials in Pediatric Surgery: Bioethical considerations. Rev Hum Med [online]. 2010, vol.10, n.1, pp. 0-0. ISSN 1727-8120.

Clinical trials are considered the best primary source of evidence; however, this kind of study is slightly used in surgery. This paper revises some of the bioethical characteristics of clinical trials in Pediatric Surgery. The main bioethical difficulties and limitations are: surgeons´ little experience in clinical trials, irreversibility of surgical treatments, need of technical training and manual experience, absence of quality criteria concerning the technique used, and influence of the learning period in the results. Possible solutions to these aspects are presented. When clinical trials are used as the best option to answer any clinical research questions in pediatric surgery, their advantages and bioethical limitations and difficulties should taken into consideration.

Palabras clave : clinical trials; bioethics; pediatric surgery.

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