随机对照试验设计及实践心得

    Experience in the Design and Implementation of Randomized Controlled Trials

    • 摘要: 随机对照试验是医学研究最重要的研究类型之一,科学的设计和规范的实施是保证研究结果真实可靠的重要前提。本文结合临床试验方案设计的准则及笔者实践心得,对开展随机对照试验的研究终点、样本量估算、随机化和分配隐藏、盲法、分析集、中期分析、在线注册、数据管理、研究报告撰写等关键环节进行了简明的总结,以期为初次开展临床试验项目的人员提供参考。

       

      Abstract: Randomized controlled trial is one of the most important types of medical research. Scientific design and standardized implementation are important prerequisites to ensure the authenticity and reliability of research results. The author briefly summarized the key points of RCT, such as research endpoint, sample size estimation, randomization and allocation concealment, blinding, analysis set, interim analysis, registration, data management and research reporting. By sharing practical experience, this paper provided help for beginners of clinical research.

       

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