天津中医药2017，Vol.34Issue(11)：738-741,4.DOI:10.11656/j.issn.1672-1519.2017.11.06
临床"合意对照"非盲设计方法初探:患者意愿的体现
"Conform-Willingness controlled Trial"design:respect patients' wishes
摘要
Abstract
Randomized controlled trial (RCT) is recognized as the golden standard of clinical trials, while, the RCT has been questioned in ethics for it cannot guarantee the subjects' right to know, and leaving potential problems for cannot ensure the subjects compliance. Therefore, the author attempts to introduce a new clinical trial method named"Conform-Willingness controlled Trial"(CWT). In"CWT", the subjects should meet the inclusion/exclusion criteria, then based on the information of medicines which researchers offered, the subjects make decision themselves on take which medicine. Matched pairs method is used to keep the balance between two groups, and then evaluate the between-group differences. The "CWT"uses a series of method to control the quality of trial, they contain the third party to collect data, and second enrollment by matched pairs method. Blinded method were adopted in statistics, and so on. "CWT"can fully guarantee the patient's right to know, to improve patients compliance, raise the clinical curative effect of experimental drugs, and ensure the reliability of the results. We hope to provide a design for clinical evaluation on methodology.关键词
合意对照/非盲设计/临床试验/伦理/意愿Key words
Conform-Willingness/open-label design/clinical trial/ethics/will分类
医药卫生引用本文复制引用
郑文科,张俊华,王辉,刘春香..临床"合意对照"非盲设计方法初探:患者意愿的体现[J].天津中医药,2017,34(11):738-741,4.基金项目
国家自然科学基金项目(8160140154) （8160140154）
教育部新世纪优秀人才项目(NCET-13-0936) （NCET-13-0936）
天津市131创新人才培养工程第三层次项目. （）
