我院抗肿瘤药物临床试验知情同意书伦理审查问题分析
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篇名: 我院抗肿瘤药物临床试验知情同意书伦理审查问题分析
TITLE: Analysis of ethical review issues of informed consent form for clinical trials of registered anti-tumor drugs in our hospital
摘要: 目的 提高注册类抗肿瘤药物临床试验知情同意书的规范性和完整性,保障受试者合法权益。方法汇总我院伦理委员会2020年7月1日-2022年7月1日进行初始审查的注册类抗肿瘤药物临床试验项目的伦理审查决议,根据我院自拟的“知情同意书质量分析表”,对其中存在问题的项目进行统计分析。结果在进行初始审查的316项注册类抗肿瘤药物临床试验项目中,知情同意书告知内容存在问题的试验项目有257项(占81.3%),以国内多中心试验、Ⅲ期试验为主。主要问题包括试验费用承担者告知模糊(占68.5%)、试验内容告知不全(占59.1%)、权益和风险告知不充分(占58.4%)、个人信息保护告知不足(占56.0%)、知情同意书表述方式不规范(占52.5%)。结论我院注册类抗肿瘤药物临床试验项目的知情同意书撰写与新版《药物临床试验质量管理规范》(GCP)的要求尚有差距,试验相关各方可采取多项措施以提高知情同意书的规范性和完整性。研究团队应严格按照新版GCP要求进行知情同意书设计,注重试验相关信息的全面告知;伦理委员会则可面向申办者和研究者提供知情同意书模板和撰写要点,不断加强审查能力、提高审查质量,切实保障受试者的安全和权益。
ABSTRACT: OBJECTIVE To promote the standardization and integrity of the informed consent form for clinical trials of registered anti-tumor drugs, and to protect the legitimate rights and interests of the subjects. METHODS The ethical review resolutions of clinical trial projects of registered anti-tumor drugs that were initially reviewed by the Ethics Committee of our hospital from July 1st, 2020 to July 1st, 2022 were summarized to statistically analyze the problematic items according to the “Quality Analysis Form of Informed Consent” prepared by our hospital. RESULTS Of the 316 clinical trials of registered anti- tumor drugs that were initially reviewed, 257 (81.3%) had problems with the contents of informed consent form, mainly domestic multi-center trials and phase Ⅲ trials. The main problems included the vague notification of the test fee bearer (68.5%), the incomplete notification of the test content (59.1%), the insufficient notification of rights and interests and risks (58.4%), the insufficient notification of personal information protection (56.0%), and the nonstandard expression of the informed consent form (52.5%). CONCLUSIONS There is still a gap between the informed consent form of the clinical trials of registered anti-tumor drugs in our hospital and the requirements of the new version of Good Clinical Practice for Drugs (GCP). The parties involved in the test can take a number of measures to improve the standardization and integrity of the informed consent form, and the research team should design the informed consent form in strict accordance with the requirements of the new GCP and pay attention to the comprehensive notification about the test. The Ethics Committee can provide the sponsor and researcher with the template of informed consent form and the key points of writing, continue to strengthen the examination ability, improve the examination quality, and effectively protect the safety and interests of the subjects.
期刊: 2023年第34卷第06期
作者: 汤晓华;毕伊;陈霞;李俊;张海伟
AUTHORS: TANG Xiaohua,BI Yi,CHEN Xia,LI Jun,ZHANG Haiwei
关键字: 药物临床试验质量管理规范;知情同意书;伦理审查;临床试验;抗肿瘤药物
KEYWORDS: Good Clinical Practice for Drugs; informed consent form; ethical review; clinical trial; anti-tumor drugs
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