中外药物临床试验中安慰剂对照的知情同意书差异研究

Differences in Placebo- control Informed Consent in Drug Clinical Trials between Chinese and Foreign Countries

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 analyze the differences of the related elements notification in the informed consent of the placebo control in the clinical drug trails between China and foreign countries. Methods： Based on Chinese and foreign ethical guidelines and principles,we retrospectively reviewed the informed consents of the clinical drug trails from the Medical Ethics Committee in the third Xiangya Hospital of the Central South University from 2009-2015. All the informed consents were reviewed by two independent researchers. Results： Finally we screened 113 copies of placebocontrol trials＇ informed consents（ 56 are Chinese） compared with foreign countries,In related placebo notification,there are four items missing obviously in the Chinese informed consents： the alternative treatment information（ 45. 9% vs 16. 7%,P = 0. 000）,the introduction of the placebo（ 37. 0% vs15. 3%,P = 0. 001）,etc.In normal notification,the missing of the Ethic Committee＇ s contact information in China is more than that of the foreign countries（ 55. 7% vs30. 6%,P = 0. 001）. Conclusion： The contents of the informed consent of placebo-control is missing significantly in Chinese clinical drug trails. The inform of background,nofault compensation and compensation still needs further improvement.