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目的研究中外药物临床试验中安慰剂对照的知情同意书中相关要素告知的差异。方法结合国内外相关指南和原则设计审查内容,采取两个研究员独立、交叉方法,对中南大学湘雅三医院伦理委员会2009—2015年受理的中外药物临床试验类研究的知情同意书各内容的告知进行审查,使用四格表χ2检验进行统计分析。结果在收集的194份知情同意书中筛选出安慰剂对照共113份(中国56份);中国临床试验安慰剂对照知情同意书在安慰剂相关告知的可替代治疗(45.9%vs16.7%,P=0.000)、安慰剂介绍(37.0%vs15.3%,P=0.001)等4项内容的缺失明显多于国外,具有统计学差异;在一般告知中伦理委员的联系方式(55.7%vs30.6%,P=0.001)的缺失多于国外。结论目前中国药物临床试验中安慰剂对照的知情同意书内容缺失情况严重,中外关于研究背景、补偿与赔偿的告知仍需进一步完善。
Objective To study the differences between the informed consent of placebo-controlled informed consent in Chinese and foreign drug clinical trials. Methods According to the relevant guidelines and principles both at home and abroad, the content of the review was designed and two researchers were employed to independently and cross-examine the contents of informed consent of Chinese and foreign drug clinical trials accepted by the Ethics Committee of Xiangya Third Hospital of Central South University from 2009 to 2015 Conducted a review, the use of four grid table χ2 test for statistical analysis. Results A total of 113 placebo-controlled (56 in China) were screened from the 194 informed consent collected; placebo-controlled informed consent for Chinese clinical trials in placebo-related alternative care (45.9% vs 16.7% (P = 0.000), placebo introduction (37.0% vs15.3%, P = 0.001) and other four items were significantly more than those in other countries with statistically significant differences; in the general notification to the ethics committee’s contact information (55.7% vs30. 6%, P = 0.001) than in foreign countries. Conclusion At present, the content of the informed consent of placebo-controlled trials in Chinese drug clinical trials is seriously lacking. The research on the background, compensation and compensation needs to be further improved by both China and foreign countries.