新生儿药理学中的临床试验设计：中心差异的影响，并借鉴儿科肿瘤协作研究的经验教训
Clinical trial design in neonatal pharmacology: effect of center differences, with lessons from the Pediatric Oncology Cooperative Research experience.
作者信息
Moran C, Smith P B, Cohen-Wolkowiez M, Benjamin D K
机构信息
Department of Pediatrics, Duke University, Durham, North Carolina, USA.
出版信息
Clin Pharmacol Ther. 2009 Dec;86(6):589-91. doi: 10.1038/clpt.2009.175.
Abstract
Survival for premature neonates has improved dramatically over the past 20 years; however, there has been minimal improvement in prematurity-associated morbidities. Morbidity rates and assessment of outcomes vary across neonatology intensive care units (NICUs). Here, we address the reasons underlying these differences, note the impact that this center variation has on trial design and interpretation, and highlight the success of the efforts in pediatric oncology to develop standards of care through the conduct of multicenter clinical trials.
摘要
在过去20年里，早产新生儿的存活率有了显著提高；然而，与早产相关的发病率却几乎没有改善。新生儿重症监护病房（NICUs）的发病率和结局评估各不相同。在此，我们阐述了这些差异背后的原因，指出这种中心差异对试验设计和解释的影响，并强调了儿科肿瘤学通过开展多中心临床试验制定护理标准所取得的成功。
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