摘要
本文旨在为加快我国儿童药物的研发,促进儿童药物临床试验的顺利开展。通过文献分析,发现我国儿童药物临床试验存在动力不足的问题,主要原因在于伦理要求高、招募工作难以开展、临床试验风险高、时间长、试验设计复杂和评价困难等,因此尝试利用真实世界证据来解决这些难题。真实世界证据的应用可以扭转儿童药物临床试验的困境,但在运用过程中存在挑战。随着真实世界证据的不断发展和完善,未来能为儿童药物临床试验环节的监管决策提供足够的依据,促进真实世界证据在儿童药物临床试验领域的应用。
The aim of the article is to promote the smooth development of clinical trials of pediatric drugs in China and to accelerate their research and development.Through literature analysis,it was found that the motivation of clinical trial of pediatric drug in China was insufficient,mainly due to high ethical requirements,difficulty in recruiting subjects,high risk,long clinical trial time,complicated trial design and difficult evaluation,etc.Thus we try to use real-world evidence to resolve these difficulties.The application of real-world evidence can reverse the dilemma of clinical trials of pediatric drug,but challenges in the application process still exist.With the continuous development and improvement of real-world evidence,it can provide sufficient basis for regulatory decisions in clinical trials of pediatric drugs in the future,and promote the application of real-world evidence in pediatric drug clinical trials.
作者
王璐
黄哲
WANG Lu;HUANG Zhe(College of Business Administration,2 Research Institute of Drug Regulatory Science,Shenyang Pharmaceutical University,Shenyang 110016,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第19期1872-1875,共4页
Chinese Journal of New Drugs
基金
辽宁省自然科学基金资助项目(2020-MS-194)
2020年辽宁省高等学校创新人才支持计划项目(202002)
沈阳市2020年度科技人才项目(RC200498)
沈阳药科大学中青年教师事业发展支持计划资助项目(ZQN2018010)
沈阳药科大学药品监管科学研究院专项基金资助项目(2021jgkx005)
2020年度辽宁省科学事业公益研究基金资助项目(2020JH4/10100018)
辽宁省教育厅重点项目(2019WZD02)。
关键词
真实世界证据
儿童药物
药物临床试验
real world evidence
children’s medicines
clinical trials of drugs