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高质量临床试验依赖于课题的前期研究方案设计及优化、中期实施质量及后期数据核查统计。临床试验设立项目执行委员会可满足以上需求。本课题组针对项目自身特点邀请享有国际声誉的妇产科学专家、统计学专家及方法学专家共同合作,成立项目执行委员会并定期举办会议。会议内容涵盖项目进展和质量控制、研究助手培训及考核、学科内涵及外延知识讲座等方面。通过项目执行委员会的设立确保了方案的可操作性,同时从不同专业背景及视角回答了研究病种相关问题,解决了如何提高临床试验研究成果产出等问题。临床试验执行委员会不仅为研究者提供了科研实践、交流学习和自我提升的平台,对规范临床试验管理、增强团队合作意识、加强多学科协作、拓展临床科研思维以及培养临床科研人才都具有深远意义。
High-quality clinical trials rely on the issue of pre-research program design and optimization, mid-term implementation of quality and post-verification statistics. Clinical trials set up the project executive committee to meet the above needs. The project team for the project’s own characteristics invited the international reputation of the obstetrics and gynecology experts, statistical experts and methodological experts work together to set up the project executive committee and hold regular meetings. The meeting covers project progress and quality control, research assistant training and assessment, subject connotation and knowledge extension and other aspects of the seminar. Through the establishment of the project executive committee to ensure the feasibility of the program, at the same time from different professional backgrounds and perspectives to answer the study of disease-related issues, to solve the problem of how to improve the output of clinical trial research results. The Clinical Trial Executive Committee not only provides researchers with a platform for scientific research, exchange and self-improvement, it is of far-reaching significance for regulating clinical trial management, enhancing teamwork awareness, strengthening multidisciplinary collaboration, developing clinical research thinking and training clinical scientists .