從RCT到臨床實踐：觀察性研究的相關性

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發布日期：2009-12-09 17:29 文章來源：丁香園
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關鍵詞： 諾和銳 諾和諾德 novonordisk Robert Ligthelm RCT 臨床 胰島素 糖尿病 　 點擊次數：

From RCT to clinical practice-Relevance of observational studies

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

目前循證治療日益被強調，隨機對照臨床試驗（RCT）的指導意義不容忽視。Ligthelm教授指出，更接近于臨床的大規模觀察性研究也能為臨床治療提供參考。門冬胰島素30作為應用多年的預混胰島素類似物，研究證據豐富，不論RCT還是觀察性研究都顯示了對HbA1c、FPG和PPG的良好控制，而且低血糖發生率低。大規模觀察性研究IMPROVE進一步顯示，門冬胰島素30可改善患者生活質量。

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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?查看分頁PPT： http://www.sipuyun.cn/2009asia_summit/article/i9916.html

編輯: xiaoyan

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