PDF(Pubmed)
Abstract：
When conducting randomised clinical trials, the choice of methodology and statistical analyses will influence the results. If the planned methodology is not of optimal quality and predefined in detail, there is a risk of biased trial results and interpretation. Even though clinical trial methodology is already at a very high standard, there are many trials that deliver biased results due to the implementation of inadequate methodology, poor data quality and erroneous or biased analyses. To increase the internal and external validity of randomised clinical trial results, several international institutions within clinical intervention research have formed The Centre for Statistical and Methodological Excellence (CESAME). Based on international consensus, the CESAME initiative will develop recommendations for the proper methodological planning, conduct and analysis of clinical intervention research. CESAME aims to increase the validity of randomised clinical trial results which will ultimately benefit patients worldwide across medical specialities. The work of CESAME will be performed within 3 closely interconnected pillars: (1) planning randomised clinical trials; (2) conducting randomised clinical trials; and (3) analysing randomised clinical trials.
摘要：
在进行随机临床试验时，方法和统计分析的选择将影响结果。如果计划的方法不是最佳质量和详细预定义的，试验结果和解释存在偏差的风险.尽管临床试验方法已经达到了很高的标准，由于实施方法不充分，有许多试验提供了有偏见的结果，数据质量差，分析错误或有偏差。为了提高随机临床试验结果的内部和外部有效性，临床干预研究中的一些国际机构已经成立了统计和方法卓越中心（CESAME）。基于国际共识,CESAME倡议将为适当的方法规划提出建议，进行临床干预研究和分析。CESAME旨在提高随机临床试验结果的有效性，最终将使世界各地的医疗专业患者受益。CESAME的工作将在3个紧密相连的支柱中进行：（1）计划随机临床试验；（2）进行随机临床试验；（3）分析随机临床试验。
