循证指南在儿科临床试验中的应用：以 StaR Child Health 为例。
Evidence-based guidelines for pediatric clinical trials: focus on StaR Child Health.
机构信息
Duke Clinical Research Institute, Durham, 2400 Pratt Street, Durham, NC 27705, USA.
出版信息
Expert Rev Clin Pharmacol. 2012 Sep;5(5):525-31. doi: 10.1586/ecp.12.52.
Clinical trials in children are challenging and filled with important ethical considerations that differ from adults. Given difficulties associated with pediatric clinical trials, off-label prescribing is a common practice in pediatrics, which can lead to adverse safety events and efficacy failures. To overcome these consequences, in the past 15 years, legislation in the USA and Europe has provided incentives to industry and increased government funding to conduct pediatric trials. Pediatric trial networks have also been formed to decrease the knowledge gap. However, challenges to performing pediatric trials and lack of standardization and guidelines regarding studies in children still exist. Standards for Research (StaR) in Child Health, begun in 2009, aims to improve the design, conduct and reporting of pediatric trials. This organization uses a consensus guideline approach involving academic, government and industry stakeholders to identify and disseminate best practices for pediatric trials. Six out of 11 planned standards are currently published.
儿童临床试验具有挑战性，其中充满了与成人不同的重要伦理考量。鉴于儿科临床试验的困难，超说明书用药在儿科是一种常见做法，这可能导致不良安全事件和疗效失败。为了克服这些后果，在过去的 15 年中，美国和欧洲的立法为行业提供了激励措施，并增加了政府资金来进行儿科试验。儿科试验网络也已经成立，以缩小知识差距。然而，开展儿科试验的挑战以及缺乏针对儿童研究的标准化和指南仍然存在。儿童健康研究标准（StaR）于 2009 年启动，旨在改善儿科试验的设计、实施和报告。该组织采用共识指南方法，涉及学术、政府和行业利益相关者，以确定和传播儿科试验的最佳实践。目前已经发布了 11 项计划标准中的 6 项。
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