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

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

摘要:

传统随机对照试验虽然设计严谨，但由于随机和盲法的存在，导致受试者在不完全知情同意的情况下入组，并在试验期内服用未知药物，为患者依从性差、影响试验结果的真实性埋下隐患，在伦理上亦存在争议。基于此，文章探索性地提出了临床"合意对照"非盲设计方法，该方法中，符合入组条件的受试者按照个人意愿选择服用药物，进入不同的观察组别。为了避免各种偏倚，该设计还采用了一系列措施以保证研究质量。"合意对照"设计将科学与伦理兼顾，旨在充分保证受试者知情权的情况下，提高受试者依从性，提高试验药物的临床疗效，并保证研究结果的可靠性，为临床评价在方法学上提供一种设计思路。

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.