仿制药生物等效性研究中健康受试者的分阶段知情同意
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摘要
生物等效性(BE)临床研究有别于Ⅱ～Ⅳ期临床试验,有其自身特点。健康受试者的知情同意是BE临床试验的一个极其重要的部分。从本院Ⅰ期临床试验中心的实践出发,发现渐进式的分阶段知情同意过程(网络平台和视频的预先教育、集体知情同意和一对一知情同意)有助于帮助受试者了解BE临床试验的具体细节,克服恐惧情绪,且能保护受试者的隐私,提高其参加试验的依从性,使BE临床试验能够获得真实准确的试验数据。
The clinical study of bioequivalence(BE) has its own characteristics, which is different from phase Ⅱ-Ⅳ clinical trial. Informed consent of healthy subjects is an extremely important part of BE clinical trials. Through the practice of our phaseⅠclinical trial center, the research doctors found that gradual process of informed consent( network platform and video education, collective informed consent, one to one informed consent) could help participants to learn details of BE trials, overcome the feeling of fear, protect participants' privacy, and improve participants' compliance, which would promote the accuracy of clinical data in BE clinical trials.
The clinical study of bioequivalence(BE) has its own characteristics, which is different from phase Ⅱ-Ⅳ clinical trial. Informed consent of healthy subjects is an extremely important part of BE clinical trials. Through the practice of our phaseⅠclinical trial center, the research doctors found that gradual process of informed consent( network platform and video education, collective informed consent, one to one informed consent) could help participants to learn details of BE trials, overcome the feeling of fear, protect participants' privacy, and improve participants' compliance, which would promote the accuracy of clinical data in BE clinical trials.
引文
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[2]雷虹艳,张忠元.论儒家文化对我国实践患者知情同意权的影响[J].中国卫生事业管理,2011,27(5):341-342.
[3]陈秀丽,陈伟,袁江帆.医疗知情同意的历史和现状[J].中国医院,2011,15(3):13-15.
[4]曹彦硕,陈学愚.人体生物等效性研究中受试者的选择和安全性考虑[J].药学进展,2018,60(9):668-674.
[5]GOLKOWSKI D,FRIEDE T,KIESER M.Blinded sample size reestimation in crossover bioequivalence trials[J].Pharm Stat,2014,13(3):157-162.
[6]庞建新,吴婷,许重远,等.我国仿制药人体生物等效性临床试验研究室建设的现状与发展路径[J].药学进展,2016,58(12):883-889.
[7]徐娜娜,陆瑶,陈瑞芳,等.中外药物临床试验知情同意书中妊娠告知差异的研究[J].中国医学伦理学,2016,29(2):293-297.
[8]AHMED A.Informed decision making and abortion:crisis pregnancy centers,informed consent,and the first amendment[J].J Law Med Ethics,2015,43(1):51-58.
[9]强美英.医疗知情同意的法伦理思考[J].医学与哲学:人文社会医学版,2010,31(5):14-16.
[10]孟竞玲.知情同意的中国式困境分析[J].医学与社会,2011,24(7):71-72.