摘要
药物临床试验是新药研发过程中的重要环节,其操作的规范程度直接关系到药物研究数据的科学性、真实性和完整性。本文通过对北京市药物临床试验机构监督检查中发现问题的归类与分析,研究加强药物临床试验机构监管、提高监管效能的措施及对策。
Clinical trial is an important step of new drug development and the compliance level of the clinical trial directly impact the scientificity, authenticity and integrity of the data in drug research. Based on the classification and analysis of the common problems which were identified during the supervision and inspection of institutions for drug clinical trial in Beijing, this article is to study how to strengthen the supervision of the institutions for drug clinical trial and the solutions and countermeasures to improve the supervision.
作者
丁正磊
丛骆骆
吴彬
Ding Zhenglei1, Cong Luoluo1, Wu Bin2.(1. Beijing Food and Drug Administration, Beijing 100053, China; 2. People＇s Government of Changping District, Beijing 102200, Chin)
出处
《中国药事》
CAS
2018年第3期299-304,共6页
Chinese Pharmaceutical Affairs
关键词
药物临床试验机构
监督检查
问题
对策
institutions for drug clinical trial
supervision and inspection
problems
countermeasures
