Afshar Kourosh, Lodha Abhay, Costei Adriana, Vaneyke Nancy
Division of Urology, University of British Columbia, Vancouver, Canada.
J Urol. 2005 Sep;174(3):835-40. doi: 10.1097/01.ju.0000169135.17634.bc.
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.
儿科外科学科的临床试验较少。这部分是由于招募参与者存在困难。这些问题的根源往往在于围绕儿童临床试验的伦理问题。我们回顾了儿科临床试验招募中的伦理障碍，并提出了在不违反公认伦理界限的情况下增加招募的建议。
使用MEDLINE、EMBASE和谷歌搜索引擎进行文献检索。审查了所有可用的北美指南。还审查了北美一个主要中心的指南，作为机构指令的示例。
确定了阻碍招募的七类伦理问题。讨论了不同研究者的观点以及他们推荐的解决这些问题的实际方法。
提出了一些建议，以帮助研究者提高涉及儿童的临床试验的获批率和招募率。
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