从RCT到临床实践：观察性研究的相关性

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发布日期：2009-12-09 17:29 文章来源：丁香园
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关键词： 诺和锐 诺和诺德 novonordisk Robert Ligthelm RCT 临床 胰岛素 糖尿病 　 点击次数：

From RCT to clinical practice-Relevance of observational studies

Dr. Robert Ligthelm
Medical Director, EHM-Hoofddorp
Rotterdam, The Netherlands

目前循证治疗日益被强调，随机对照临床试验（RCT）的指导意义不容忽视。Ligthelm教授指出，更接近于临床的大规模观察性研究也能为临床治疗提供参考。门冬胰岛素30作为应用多年的预混胰岛素类似物，研究证据丰富，不论RCT还是观察性研究都显示了对HbA1c、FPG和PPG的良好控制，而且低血糖发生率低。大规模观察性研究IMPROVE进一步显示，门冬胰岛素30可改善患者生活质量。

In the past there has been an unprecedented development in clinical research methods to address the needs of diverse clinical specialties and practices. As such, trial designs and statistical methodology have become sophisticated. One design that has proven to be imperative to evaluating the efficacy and tolerability of a new drug is the randomised clinical trial (RCT). The RCT study design, like any, can bring drawbacks and challenges, leaving gaps in the evidence-base that observational studies are ideally suited to fill. Ongoing improvements in study methods and advances in statistical analysis have brought observational studies to the forefront of research design thereby remaining as an important source of evidence. Today Dr Ligthelm will provide an overview of the relevance of observational studies in clinical research and how trials with NovoMix® 30 show comparable results versus those conducted as RCT.

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