血液制品临床研究现状及要点浅析
Current status and key points analysis for clinical research on blood products
倪娜 1姜山 2冯静仪 2刘嘉欣 2王俊龙 1陈桂良3
作者信息
- 1. 中国医药工业研究总院药物临床研究中心,上海 200437
- 2. 上海益临思医药开发有限公司,上海 200437
- 3. 上海药品审评核查中心,上海 201203
- 折叠
摘要
血液制品作为一类特殊的生物制品,在开展临床研究时,除要符合临床研究的相关法律法规外,在方案设计、项目管理、数据管理及统计分析等各方面也有需要进行特殊考虑之处.该文主要从血液制品临床研究的角度出发,对临床研究的现状、方案设计要点及项目管理要点进行浅析,为血液制品的临床研究提供一些研究思路,拓展产品应用,提升产品临床研究效率和质量.
Abstract
As a special biological product,blood products should not only comply with relevant laws and regulations of clinical research,but also need to be considered in the aspects of protocol design,project management,data management,and statistical analysis.This article mainly analyzed the current situation,key points of protocol design,and project management from the perspective of clinical research on blood products,to provide some research ideas for the clinical research of blood products,expand product applications,and improve the efficiency and quality of product clinical research.
关键词
血液制品/临床研究/方案设计/项目管理Key words
blood products/clinical research/protocol design/project management引用本文复制引用
出版年
2024
NETL
NSTL
万方数据