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建立中国高质量临床证据面临的机遇与挑战

Opportunities and challenges in establishing high-quality clinical evidences in China

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【作者】 武阳丰;

【Author】 Wu Yangfeng;Peking University Clinical Research Institute;

【机构】 北京大学临床研究所;

【摘要】 过去十年我国开展临床研究的数量增长迅速,质量也有了明显提高,无论是获批一类新药的数量,还是在国际医学顶刊发表临床研究论文的数量均前所未有。然而,应该认识到,在所有临床研究中,能够提供高质量临床证据的研究所占比例仍很低,整体创新水平和国际竞争力仍不足。改变这一局面,应坚持面向人民生命健康,走创新驱动发展和高质量发展之路。我们还需要清楚地认识中国开展高质量临床研究具有的优势和劣势,抓住时代赋予的机遇,克服潜在的困难,扬长补短,方能使高质量的临床研究方兴未艾,进而引领我国临床医学进入世界一流行列,对世界医学的发展做出一个负责任大国应有的贡献。为此,应大力开展临床科学家的培养,大力加强临床研究技术支撑平台的建设和临床研究规范化管理体系建设,大力开展临床试验相关知识的科学普及。

【Abstract】 In the past decade, the number of clinical research conducted in China has grown rapidly, and the quality has also significantly improved. Both the number of approved new drugs and the number of clinical research published in top international medical journals have never been higher. However, it should be recognized that the proportion of research that can provide high-quality clinical evidence in all clinical studies is still very low, and the overall level of innovation and international competitiveness are still insufficient. To change this situation, we should hold up ‘the principle for people′s lives and health’ and follow the path of the development by innovation and high-quality development. We also need to have a clear understanding of the strengths and weaknesses of conducting high-quality clinical research in China, seize the opportunities and prevent threats, in order to make high-quality clinical research flourish and further lead China′s clinical medicine to the world-class and make contributions to the development of medicine of the world that are commensurate to a responsible major country. Therefore, efforts should be made to cultivate clinical scientists, strengthen the construction of clinical research technology support platforms, strengthen the construction of clinical research management and regulation systems, and promote the scientific popularization of clinical trial related knowledge.

【关键词】 临床研究; 证据; 质量; 行动建议; 中国;
【Key words】 Clinical study; Evidence; Quality; Action recommendations; China;
  • 【文献出处】 中国脑血管病杂志 ,Chinese Journal of Cerebrovascular Diseases , 编辑部邮箱 ,2023年06期
  • 【分类号】R-3
  • 【下载频次】31
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