摘要
消化性溃疡出血为临床常见内科急症之一,有一定的病死率。近年来在我国,抑酸药用于该治疗领域的药物研发较为活跃。目前,国内外药品监管机构尚未发布相关技术文件可供参考。本文基于临床研发现状,同时结合在药品技术审评中发现一些常见共性问题,就临床试验设计与评价重点关注内容,从技术审评角度提出一些考虑,以期为开展药物临床试验提供参考,进而促进有临床价值药物尽早上市,更好地满足患者的临床需求。
Peptic ulcer bleeding is one of the common medical emergencies in clinical practice,and has a certain mortality rate.In recent years,the development of acid-suppressive drugs for this therapeutic field has been active in China.Currently,there are no relevant technical guidelines for reference from domestic and foreign drug regulatory agencies.This article puts forward some considerations for the key points in the design and evaluation of clinical trials from the perspective of drug evaluation,based on the current status of clinical development and some common problems found in drug evaluation,aiming to providing references for conducting drug clinical trials and promote drugs of clinical value to market soon to better meet the clinical needs of patients.
作者
陈颖
鲁爽
CHEN Ying;LU Shuang(Center for Drug Evaluation,National Medical Products Administration,Beijing,100022,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2020年第14期1576-1582,共7页
Chinese Journal of New Drugs
关键词
消化性溃疡出血
临床试验设计
新药研发
peptic ulcer bleeding
clinical trial design
new drug development
