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儿童临床试验的伦理问题:欧洲视角

Ethical issues of clinical trials in children: a European perspective.

作者信息

Sammons H

机构信息

Academic Division of Child Health, University of Nottingham, The Medical School, Clinical Sciences, Derbyshire Children's Hospital, Derby, UK.

出版信息

Arch Dis Child. 2009 Jun;94(6):474-7. doi: 10.1136/adc.2008.149898. Epub 2009 Feb 10.

Abstract

Children should not be harmed by their participation in clinical trials, therefore should no clinical trials be performed? This is a view that needs to be balanced as clinical trials provide the evidence we need to allow children safe and effective prescribing of medicines. Therefore, is it unethical not to involve this population in research? This review looks at new ethical guidance released to support the recently introduced European legislation for the licensing of medicines.

摘要

儿童参与临床试验不应受到伤害,那么就不应进行任何临床试验了吗?这是一种需要权衡的观点,因为临床试验为我们给儿童安全有效地开药提供了所需的证据。因此,不让这一人群参与研究是否不道德呢?本综述探讨了为支持最近出台的欧洲药品许可立法而发布的新伦理指南。

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