临床医生如何做好RCT研究  

How can Clinicians Do A Good Job in RCT Research

作　　者：沈恺妮 李剑[1] SHEN Kaini;LI Jian(Department of Hematology,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100730,China)

机构地区：[1]中国医学科学院北京协和医院血液内科,北京100730

出　　处：《协和医学杂志》2023年第3期617-620,共4页Medical Journal of Peking Union Medical College Hospital

基　　金：中央高校基本科研业务费专项资金(3332021002)。

摘　　要：随机对照试验(randomized controlled trial,RCT)是证实临床干预措施有效性的最佳研究手段。一项好的RCT应以具备临床意义和科学价值的主题为核心,重点关注干预及对照的设立、随机化方式及研究终点的选择。在实施过程中,把握伦理申请、研究注册、数据收集及研究定期审核等细节,从而保证研究的科学性及结果的可信度。Randomized controlled trial(RCT)provides the most valid means of establishing the efficacy of clinical therapeutics.A good RCT should be based on topics with clinical significance and scientific value,and focus on the establishment of intervention and control,the method of randomization and the selection of primary endpoints.During the implementation process,details such as ethics application,research reg⁃istration,data collection and regular review of the research are of great value to ensure the scientific validity of the trials and the credibility of the results.

关 键 词：随机对照试验 干预 随机化 主要研究终点 

分 类 号：R181.2[医药卫生—流行病学] R45[医药卫生—公共卫生与预防医学]