我国临床试验伦理审查培训现状与对策

Current Status and Strategies of Training on Ethics Reviews on Clinical Trials in China

目的通过问卷调查,了解和分析中国临床试验伦理审查培训的现状和问题。方法对参加2009年6月开展的首届临床试验伦理审查培训班学员进行问卷调查。结果发放问卷60份,回收34份,回收率56.7%,调查结果显示,78.1%(25/32)的学员表示达到学习目的,12.5%(4/32)由于语言障碍没能达到学习目的。学员们普遍认为培训班各专题内容与质量对其非常有帮助,85.2%(23/27)认为伦理审查工作存在困难为,包括相关法规支持不够(60%,19/32)、方法学欠缺(41%,13/32)、培训缺乏(38%,12/32)等。结论反馈率虽不高,但提示建立我国伦理学培训基地和伦理审查专业人才培训的重要性,可适时考虑将伦理学审查纳入医学生必修课;培训应基于不同对象的需求分层进行,重视教学方法、讲义和教学资料的相关性,授课结合案例分析、讨论和经验交流是一种效果较好的培训方式。

Objective To explore the current problems of training on ethics reviews in clinical trials in China.Methods We designed a quantitative survey to collect participants＇ feedbacks on the training workshop on ethics reviews,which included contents,arrangement and structure,relevant to the workshop and their di culties on ethics review work.Results A total of 60 questionnaires were sent and the response rate was 56.7%（34/60）.A total of 120 participants from 18 provinces of China.Most of them were members of the virtual research center of evidence-base medicine of the Ministry of education.A total of 78.1%（25/32） participants thought they achieved their purpose after training,and 12.5%（4/32） did not meet their needs due to the poor language.e feedbacks of contents and quality of the workshop on ethics were shown in Table 1.e top useful contents（cents in 8-10） were：clinical trial registration,policies of WHO and China（93.8%,30/32）,data management and quality control in clinical trials,the roles of clinical trial registries and ethics committees（93.3%,28/30）,transparency in clinical trials（93.3%,28/30）,informed consent and beyond（91.8%,31/34）,and how to approach ethical review case studies（90.9%,30/33）,etc.Nobody considered workshop of less help.The majority（85.1%,23/27） thought difficulties on ethic reviews existed and the main difficulties include：short of operational administrative rules（82.6%,19/23）,poor training opportunity（52.1%,12/23）,less supports from administrative（30.4%,7/23） and nancial（21.7%,5/23）,etc.e relevance（8-10 cents） to ethics workshop was：methods of teaching 75.9%（22/29）,PPT 75%（21/28） and materials 42.9%（12/28）.Conclusions There is some limitations in the rst workshop on ethic reviews due to the lower response rate.However,it still shows the importance of training on ethics reviews.Training strategies should focus on different participants＇ needs and the relevance to methods of teaching,and materials,etc.Workshopadopted lectures,cases studies analysis,more discussions and necessary translation will be welcome.